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Anteris Technologies Global CorpMaple Grove, MN
Anteris is a science-driven structural heart company that is redefining expectations and advancing the field through cutting-edge solutions focused on restoring native-like physiology versus treating symptoms of structural heart disease. We are currently developing a new class of TAVR designed to mimic the performance of a healthy aortic valve. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team. Reporting to the Director of Regulatory Affairs, the Regulatory Affairs Specialist will lead and execute regulatory submission and approval activities for the company's medical device products, with a primary focus on U.S. FDA submissions. This role will also provide support for international regulatory submissions outside North America. The Specialist will coordinate with FDA and international regulatory bodies throughout the submission and review processes to ensure timely approvals and ongoing compliance with applicable regulations and corporate standards. In addition, this role will support regulatory aspects of clinical studies. This position will contribute to a collaborative team environment with the unique opportunity to directly impact our mission, vision, and values as we take the company to the next level of success. At Anteris, you'll be part of a high-caliber team advancing a transformative therapy for aortic stenosis. We value accountability, objectivity, respect, teamwork, integrity, and courage, and we're united by a shared purpose: improving patient lives through disruptive innovation. We're building something remarkable-and we're just getting started. This role may be filled at varying levels, e.g., Senior or Principal, depending on the candidate's previous experience. Key Responsibilities Drive regulatory planning and execution to ensure alignment with business and functional goals and priorities Prepare and review FDA submissions and other regulatory documents including 510(k)s, PMAs, PMA Supplements, PMA Amendments, Investigational Device Exemptions (IDE), Humanitarian Device Exemptions (HDE), Humanitarian Use Device (HUD) Applications and periodic study reports as assigned Actively engage as the Regulatory Affairs representative on project teams Serve as a liaison with the Regulatory Agencies globally by conducting negotiations with agency reviewers as needed Review and interpret regulatory requirements as they relate to company products and procedures, clinical studies, testing or records keeping and ensure that they are communicated through company policies and procedures Document review and approval to assure regulatory compliance (manufacturing process and product, change order, promotional review) Ensure that regulatory requirements are fully understood, implemented and/or mitigated in new product, clinical, marketing, and other business processes Communicate regulatory strategies and project status to internal stakeholders (Clinical Affairs, R&D, Marketing, Quality, Manufacturing) Interact with and influence external regulatory agencies and trade associations Author, review, and/or approve internal operating procedures related to regulatory affairs. Coordinate timely renewal of certificates, licenses, and global product registrations. Support Quality Assurance in maintaining ISO/CE Mark certifications and related regulatory audits. Participate in complaints process in assessing and reporting to appropriate agencies Skills, Knowledge, Experience & Qualifications Bachelor's degree in science or engineering required. Advanced degree is a plus. Minimum of 5 years of experience in Regulatory Affairs; 8+ years' experience preferred Minimum of 5 years' medical device industry experience including Pre-Sub, IDE, 510(k), De Novo, PMA, Technical File/Design Dossier, and HDE submissions. Experience with Global Regulatory Agencies (Notified Bodies, Competent Authorities, Health Canada, TGA) preferred. Class III medical devices experience required; cardiovascular experience preferred. Experience with tissue heart valves is a plus. Working knowledge of FDA requirements, guidance documents, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards Good understanding of product development process and design control through knowledge of US FDA and international medical device regulations Must have ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully and professionally with all levels of personnel. Strong interpersonal, analytical, writing, and organizational skills, including the ability to find creative regulatory solutions in "grey" areas. Demonstrated ability in project management skills to plan, conduct and implement system assessments and robust submissions RAC Certification preferred. What We Offer: Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies. Collaborative and dynamic work environment with a culture of innovation and excellence. Competitive compensation package, including salary, performance-based bonuses, and stock options. Career development opportunities and a chance to be part of a growing company that values its employees. Health and Wellness Offerings Medical, Dental, and Vision Plans Flexible Spending Account (FSA) 401k + Company Match Life, AD&D, Short Term and Long-Term Disability Insurance Bonus Plan Eligibility Employee Equity Program Paid Holidays & PTO Employee Assistance Program Inclusive Team Environment Job Types: Full-time, Contract Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations. Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.

Posted 30+ days ago

Durable Medical Equipment Repair Technician-logo
Quipt Home MedicalAthens, GA
Description If you have compassion and the passion for helping others, then we want you to join our growing team! Quipt Home Medical is a rapidly growing leader in the provision of clinical respiratory equipment and service in the durable medical equipment industry. Let's start with what's important to you. The Benefits..... Medical Insurance- multiple plans to choose from Dental & Vision Insurance Short Term Disability & Long Term Disability Options Life Insurance Generous PTO plan Paid Holidays 401K 401K match Competitive Pay Position: Durable Medical Equipment Repair Technician General Description: The Durable Medical Equipment Repair Technician will be responsible for troubleshooting, diagnosing, and repairing durable medical equipment. Schedule: Monday-Friday 8 hour shifts evening or weekends may be required for emergency repairs Job Type: Full Time Duties/Responsibilities: Inspects and repairs company's medical and related technical equipment in accordance with manufacturer's specifications. Inspects and repairs patient/customer's medical equipment in accordance with manufacturer's specifications. Repairs, calibrates, and maintains equipment. Safety tests medical equipment and company's structural environment to ensure patient and staff safety from electrical or mechanical hazards. Consults with staff to ascertain that equipment functions properly and safely. Assembles medical equipment per manufacturer's specifications. Maintains adequate supply of repair parts. Can demonstrate and explain correct operation of equipment. This includes but is not limited to identifying hazmat symbols, wearing protective safety gear and red-bagging and handling contaminated equipment in a safe manner. Documents the functional checks and repairs for company and patient/customer's equipment. May have to assist Delivery Drivers in preparing, loading and unloading trucks/vans. Maintains work area and tools in a clean and orderly manner. Follows the safety program and adheres to Occupational Safety and Health Administration (OSHA) guidelines to reduce work-related injuries. To Succeed: Strong mechanical skills are necessary as is the ability to remain patient focused when repairing, maintaining, or setting up DME equipment The knowledge and ability to operate smart devices (e.g., smart phone, tablets), computers and hand held scanning devices are required The ability to read, write and follow written and oral instructions is required to ensure accurate completion of DME equipment repairs, maintenance, and set up The ability to protect and maintain the confidentiality of patient protected health information and follow standard operating procedures to ensure compliance with CHAP and HIPAA is required Good organization and prioritization skills are required to plan and stage equipment as describe A safety orientation is required to perform work (e.g., driving, delivery, set up, loading and stocking of durable medical equipment as described) and follow safety operating procedures Requirements Job Requirements: High school diploma or general education degree (GED); A current state issued driver's license is required Clean driving record for the past 3 years Pass a background check The ability to utilize basic tools e.g., wrench, screwdrivers etc. to set up or repair durable medical equipment Experience in the healthcare or medical fields in which incumbents have worked with durable medical equipment is preferred but not required. One year previous repair or warehouse experience preferred Physical Requirements: Must be able to lift up to 80 pounds at times. Must have the ability to lift, maneuver and assemble and disassemble large and awkward durable medical Periodically, (approximately 50%-75% of the day) standing, walking, bending, twisting, grasping, squeezing, kneeling, stooping, crouching, crawling, reaching, reaching above the shoulder is required while transporting, setting up, taking apart and moving medical equipment as described Frequent bending, twisting, grasping and squeezing and occasional kneeling, climbing stairs, reaching above the shoulder is required to transport and set up medical equipment as described Occasionally, climbing of stairs is required to transport durable medical equipment to or from a particular room, location or vehicle

Posted 30+ days ago

Medical Assistant II, Cardiology-logo
Sutter HealthFolsom, CA
We are so glad you are interested in joining Sutter Health! Organization: SMF-Sutter Med Foundation- Central Position Overview: Provides clinical and clerical support to providers and members of the patient care team(s) by performing a variety of back office and patient-related tasks supporting the delivery of high-quality patient care. Helps ensure smooth patient and workflow within the department and assists the patient care team in implementing the medical plan of care. Integrates education, technical competence, and patient interaction skills to gain confidence and cooperation from the patient, their family/support group, and other healthcare providers. Performs all duties under the direction of a clinician. Job Description: EDUCATION: HS Diploma: High School Diploma or General Education Diploma (GED) Other: Completion of a course of study consistent with the requirements for Medical Assistants as specified by the Medical Board of California. (Must present diploma within 90 days) OR Other: Equivalent Sutter Health Training program (approved for SBMF and SCH) OR Completion of Sutter Health on-the-job training equivalent to one year CERTIFICATION & LICENSURE: BLS-Basic Life Support Healthcare Provider MA Certification by a California Medical Board recognized agency is required to be eligible for incentive (to be implemented in 2025) Phlebotomist License- Required to obtain the first year of employment TYPICAL EXPERIENCE: 1 year of recent relevant experience. SKILLS AND KNOWLEDGE: General knowledge of various medical procedures, views, and equipment. Basic understanding of human anatomy, physiology, pathology, and medical terminology. Competent and validated in basic Medical Assisting skills such as taking vital signs, preparing patients for exam, and administering injections. Ability to interpret a variety of data and instructions, furnished in written, oral, diagram, or schedule form. Possess written and verbal communications skills to explain sensitive information clearly and professionally to diverse audiences, including non-medical people. Well-developed time management and organizational skills, including the ability to prioritize assignments and work within standardized operating procedures and scientific methods to achieve objectives and meet deadlines. General knowledge of computer applications, such as Microsoft Office Suite (Word, Excel and Outlook) and electronic health record (EHR). Ability to prioritize assignments and work within standardized policies, procedures, and scientific methods to achieve objectives and meet deadlines. work independently, as well as be part of the team, including accomplishing multiple tasks in an environment with interruptions. identify, evaluate and resolve standard problems by selecting appropriate solutions from established options. build collaborate relationships with peers and other healthcare providers to achieve departmental and corporate objectives. TRAVEL Travel required as needed. Job Shift: Days Schedule: Full Time Shift Hours: 8 Days of the Week: Monday- Friday Weekend Requirements: As Needed Benefits: Yes Unions: No Position Status: Non-Exempt Weekly Hours: 40 Employee Status: Regular Sutter Health is an equal opportunity employer EOE/M/F/Disability/Veterans. Pay Range is $28.71 to $34.45 / hour The salary range for this role may vary above or below the posted range as determined by location. This range has not been adjusted for any specific geographic differential applicable by area where the position may be filled. Compensation takes into account several factors including but not limited to a candidate's experience, education, skills, licensure and certifications, department equity, training and organizational needs. Base pay is just one piece of the total rewards program offered by Sutter Health. Eligible roles also qualify for a comprehensive benefits package.

Posted 3 weeks ago

Medical Laboratory Technician - Full Time, Evenings, Allegheny General Hospital-logo
Highmark Inc.Pittsburgh, PA
Company : Allegheny Health Network Job Description : $5,000 Sign on Bonus for Eligible Candidates GENERAL OVERVIEW: Performs routine and highly complex laboratory analyses on clinical specimens in various sections of the laboratory under supervision. ESSENTIAL RESPONSIBILITIES: Performs a variety of routine and complex procedures using established criteria to provide quality clinical information. Verifies analytic accuracy, precision, sensitivity and linearity for test methods. (50%) Operates, calibrates, checks and maintains instrumentation. Recognizes problems with quality control and test procedures and takes appropriate action to ensure quality clinical information. (30%) Participates in programs to keep updated with current and changing technologies. (5%) May collect and process patient specimens in accordance with laboratory policies and procedures and within the expected time frames. (5%) Maintains the cleanliness of the work area and adequate supplies for efficient laboratory operations. (5%) May mentor MT/MLT, phlebotomy, and lab processor students and new employees in laboratory testing following AHN policies and procedures. (5%) Performs other duties as assigned or required. QUALIFICATIONS: Minimum Associates degree in ASCP eligible program or equivalent. Meet ongoing education requirements for certification. Preferred Clinical laboratory experience. Medical Laboratory Technician or equivalent Disclaimer: The job description has been designed to indicate the general nature and essential duties and responsibilities of work performed by employees within this job title. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job. Compliance Requirement: This job adheres to the ethical and legal standards and behavioral expectations as set forth in the code of business conduct and company policies. As a component of job responsibilities, employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times. In connection with this, all employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures as well as all data security guidelines established within the Company's Handbook of Privacy Policies and Practices and Information Security Policy. Furthermore, it is every employee's responsibility to comply with the company's Code of Business Conduct. This includes but is not limited to adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements. Highmark Health and its affiliates prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities and prohibit discrimination against all individuals based on any category protected by applicable federal, state, or local law. We endeavor to make this site accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact the email below. For accommodation requests, please contact HR Services Online at HRServices@highmarkhealth.org California Consumer Privacy Act Employees, Contractors, and Applicants Notice

Posted 30+ days ago

W
Well Street Urgent CareMadison, OH
University Hospitals Urgent Care - Delivering Quality Care with Purpose This position will float between Madison & Ashtabula. Are you a passionate Medical Assistant or Paramedic looking for a dynamic and rewarding career? Join University Hospitals Urgent Care, where you'll make a meaningful impact in a fast-paced clinical environment while enjoying work-life balance and professional growth opportunities. As a Medical Assistant, you will be a key part of our healthcare team, providing hands-on patient care and ensuring smooth clinic operations. This role is ideal for those who thrive in a high-energy, team-oriented setting and are committed to delivering exceptional care. Why You'll Love Working Here: LIFE-Work Balance & Flexible Schedule: Full-time (3-day/12-hour shifts, 8 AM - 8 PM) - No overnight shifts, so you can prioritize both your career and personal life! Competitive Pay & Benefits: Medical, Dental, Vision, Prescription, Pet Insurance & more Paid Time Off & Holidays: Recharge and take care of yourself 401K with Company Match: Plan for your future Professional Growth: Certification reimbursement, leadership opportunities & professional development Wellness Support: Employee Assistance Program (EAP) & Wellness Initiatives Key Responsibilities: Patient Preparation: Assist with preparing patients for examinations and treatments, ensuring they are comfortable and well-informed. Triage & Vital Signs: Perform triage and take vital signs accurately. Documenting Patient History: Obtain and document detailed patient history in our Electronic Medical Record (EMR) system in a timely manner. Lab Specimens: Collect routine laboratory specimens, including blood, urine, and oral swabs. Medication & Injections: Administer medications and non-intravenous injections, including intramuscular, subcutaneous, and intradermal injections. Clinical Procedures: Start IVs, place catheters, and perform splinting when necessary. Clinical & Laboratory Procedures: Perform basic clinical, aseptic, and laboratory procedures to support patient care. Occupational Medicine: Assist with our Occupational Medicine services, including drug screening, breath alcohol testing, audiograms, and pulmonary function testing, while adhering to company protocols. Compliance: Enforce and maintain healthcare regulatory requirements, including HIPAA and OSHA compliance. Administrative Duties: Perform office procedures and general administrative tasks; proficiently operate office medical equipment. Quality Assurance: Oversee compliance with quality assurance programs, CLIA waived laboratory requirements, and patient result trackers. Travel Requirement: Support staffing and operational needs by traveling to other Prisma Health Urgent Care locations as required. Required Qualifications: Certification: Must be certified or registered as a Paramedic or Medical Assistant through an accredited organization (e.g., AMT for RMA/NHA or AAMA for CMA). Experience: 1+ year of healthcare experience preferred (urgent care or ER a plus); willing to train outstanding new graduates Skills: Proficiency in venipuncture, injections, and clinical procedures Technical Skills: Experience using Electronic Medical Records (EMR) software, EPIC preferred Flexibility: Ability to work 12-hour shifts, weekends, and holidays Team Player: A positive, proactive approach to patient care and collaboration At University Hospitals Urgent Care, we believe in kindness, excellence, empowerment, resilience, and proactive service. If you're looking for a career where your contributions truly matter, apply today and be part of something bigger! #WUCBoost

Posted 2 weeks ago

PRN Medical Assistant-logo
Everside HealthHilbert, WI
Marathon Health is a leading provider of advanced primary care in the U.S., serving 2.5 million eligible patients through approximately 630 employer and union-sponsored clients. Our comprehensive services include advanced primary care, mental health, occupational health, musculoskeletal, and pharmacy services, delivered through our 680+ health centers across 41 states. We also offer virtual primary care and mental health services accessible in all 50 states. Transforming healthcare delivery with a patient-first approach, we prioritize convenient access to both in-person and virtual care, resulting in improved health outcomes and significant cost savings. Committed to inclusivity and collaboration, we foster a positive work environment and recruit exceptional talent to ensure expertise and compassion in healthcare delivery. Marathon has been recognized as a five-time Modern Healthcare Best Places to Work in Healthcare winner and a six-time Best in KLAS award winner for employer-sponsored healthcare services. About Us At Marathon Health we are building the most trusted, accessible and personalized healthcare experience alongside our patients and clients. With 20+ years' experience from our shared organizations, we hold a unified goal of building deep, trusted and lasting relationships with our patients and clients. As Marathon Health, we are guided by our core principles of Patients First, Courage, Ingenuity, Community, and Fun. About the Role We are currently looking for an experienced Medical Assistant to join our PRN team. The Medical Assistant is a key component of our care team and works closely with a primary care physician to deliver excellent patient care and provide an exceptional guest experience to our patients. Because of our unique model, our Medical Assistants oversee the full spectrum of the patient experience- acting both as a Medical Receptionist as well as assuming clinical responsibilities of a Medical Assistant. Essential Duties and Responsibilities The following duties and responsibilities generally reflect the expectations of this position but are not intended to be all-inclusive. Escorts patients to room and ensures that exam rooms are thoroughly cleaned and stocked Reviews previous medical information and gathers any relevant updated health information from the patient to inform the provider Take vitals, perform blood draws, give injections, bandage wounds, assist with procedures. Work with the contracted labs for additional tests Prepares and administers approved medications and immunizations via oral, topical, inhaled, intramuscular, subcutaneous or intradermal at the direction of and upon written order from the Provider Partners with other members of the care team to develop individual patient plan of care including identifying and working to address gaps in care Front desk duties, including: patient scheduling, medical record requests and abstraction, documentation, coordinate specialist visits, referrals, and other care outside of the clinic, check-in, check-out, etc. Records accurate and pertinent data in the medical record according to documentation guidelines Process test results and provide the patient with timely results via e-message, mail or phone as directed in written instructions by the Provider Participates in outreach to patients to drive engagement among eligible patient groups Maintains clinical and office supplies and equipment for treatments About You Minimum of 1 year of experience working as a Medical Assistant, preferably in Primary Care. May vary based on clinic needs Graduation from a formal Medical Assistant program or other related program National or state-specific MA certification or registration is strongly preferred. MA certification or registration is required for employment in States where certification/registration is required. CPR/BLS certification required at time of start date Phlebotomy experience is preferred Pay Range: $20.00-$26.00/hr The actual offer may vary dependent upon geographic location and the candidate's years of experience and/or skill level.

Posted 30+ days ago

U
University Of Miami Miller School Of MedicineMiami, FL
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet. $10,000 Sign-On Bonus The Surgery- Histo & Immuno department has an exciting opportunity for a full time Medical Technologist 2 (H) position. The incumbent performs microbiological, molecular biological and immunological tests on body specimens to provide data for use in treatment and diagnosis of disease. Moreover, the incumbent facilitates quality assurance and instrument maintenance. CORE JOB FUNCTIONS Verifies identification of specimen with physicians' orders, prepares specimens for testing, and handles all specimens in a safe and careful manner. Analyzes results of testing and interprets abnormal or unusual results. Researches and prepares all pertinent patient data and refers all data and testing results to pathologists for evaluation and sign-out. Calibrates equipment, orders supplies, and maintains inventory of relevant forms and materials. Recognizes test inconsistencies and takes appropriate corrective action while supporting laboratory coworkers in resolution of similar problems. Administers quality-control tests, according to procedure, and maintains appropriate data recording. Assists with orienting and training employees on laboratory techniques and operations. Adheres to University and unit-level policies and procedures and safeguards University assets. This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary. CORE QUALIFICATIONS Bachelor's degree in relevant field. Current Florida Medical Technologist License. Minimum 2 years of relevant experience. DEPARTMENT ADDENDUM Department Specific Functions Follows all safety precautions and regulatory rules to safeguard patient confidentiality. 2. Performs instrument maintenance, calibration, and verification; as applicable. 3. Performs and verifies quality-control testing, according to procedure, and maintains appropriate data recording. 4. Perform High Complexity Tests adhering to approved Standard Operating Procedures as follows: Molecular / Histocompatibility Area: - Infectious Disease Testing by PCR using Ingenious / Elitech, Roche / Cobas Ampliprep and Real Time PCR instruments (7500) - HLA typing by Sequence Specific Primer Technique (QuantStudio) and Sequence Specific OligoProbe (Luminex) - High Resolution HLA Typing, APOL1 and Gene Rearrangement Assays by Next Generation Sequencing. Immunology / Histocompatibility Area: - Red Blood Cell Typing (ABO/Rh & A/AB Subtyping- Flow Cytometry Technique for Immunophenotyping and Cell Activation Panels.- Lymphocyte Crossmatch & Endothelial Cells Crossmatch by Flow Cytometry and Complement Dependent Cytotoxicity Assay- Solid Phase platform for HLA Antibody Detection and Identification and Complement fixing Antibodies (Luminex)- Luminex Panel for Human Cytokine Level Quantification Core & Serology Area:- Mass Spectrophotometry for quantification of Immunosuppressant Drug Levels in blood- Manual & Automated ELISA based assays for Infectious Disease Antibody & Antigen detection and / or quantification- Other Hematology & Microbiology Procedures 5. Uses Specific Test- Analysis Software for raw data analysis and assigns the results accordingly. 6. When results are not within laboratory's acceptable criteria; identify problem(s) that might adversely affect test performance and determine cause of errors. 7. Researches and prepares all pertinent patient data and refers all data and testing results to pathologists for evaluation and sign-out. 8. Reports all results in the current Laboratory System and in UNET, if applicable. 9. Place orders and maintains inventory of disposable supplies and reagents, as applicable. UNIVERSITY OF MIAMI Core_Medical Technologist 2 (H) 10. Meets Turn Around Time (TAT) for all tests assigned. 11. Reports Critical Value to the requestor following current IHL Policy, if applicable 12. Performs OnCall Duties in the assigned area / rotation, responding promptly to any Call-Back situation. 13. Participates in Proficiency Testing, Instrument Correlation, Method Comparison, and / or Validation Studies, as assigned. Meets deadline for these other projects / assignments. 14. Assumes lead duties and acts as a resource to staff. 15. Orients and trains employees on laboratory techniques and operations, as assigned. 16. Obtain 12 Continuing Education Credits in the Histocompatibility Area per year, in addition to those credits required by the State of Florida. Department Specific Qualifications Education:Bachelor's Degree in relevant field. Certification and Licensing: Florida Medical Technologist License is required. Certified Histocompatibility Technologist / Specialist desired Experience . Minimum 2 years of relevant experience. #LI-GD1 The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more. UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for. The University of Miami is an Equal Opportunity Employer- Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information. Job Status: Full time Employee Type: Staff Pay Grade: H11

Posted 30+ days ago

Medical Assistant - Hamburg And Northtown (Full Time)-logo
Schweiger DermatologyHamburg, NY
Schweiger Dermatology Group is one of the leading dermatology practices in the country with over 400 healthcare providers and over 170 offices in New York, New Jersey, Pennsylvania, Connecticut, Florida, Illinois, Missouri, Minnesota, and California. Schweiger Dermatology Group provides medical, cosmetic, and surgical dermatology services with over 1.5 million patient visits annually. Our mission is to create the Ultimate Patient Experience and a great working environment for our providers, support staff and all team members. Schweiger Dermatology Group has been included in the Inc. 5000 Fastest Growing Private Companies in America list for seven consecutive years. Schweiger Dermatology Group has also received Great Place to Work certification. To learn more, click here. Schweiger Dermatology Group's Ultimate Employee Experience: Multiple office locations, find an opportunity near your home Positive work environment with the tools to need to do your job and grow Full time employees (30+ hours per week) are eligible for: Medical (TeleHeath included), HSA/FSA, Dental, Vision on 1st of the month after hire date 401K after 30 days of employment Your birthday is an additional personal holiday Company Sponsored Short Term Disability Pre-tax savings available for public transit commuters Part-time employees (less than 30 hours) are eligible for: Dental and Vision on 1st of the month after date of hire 401K after 30 days of employment Employee discounts on Schweiger Dermatology Group skin care products & cosmetic services Job Summary: Full-Time Medical Assistant at our Hamburg and Northtown Offices. The Medical Assistant is responsible for performing the highest quality of medical, clinical, and clerical tasks in a medical setting. Previous healthcare experience is required. Schedule: Full time, 30+ hours per week. Availability Monday through Friday with rotating Saturdays within operating hours of 7:00am- 7:30pm Flexibility to help cover in a team environment is needed. Medical Assistant Promote a professional and welcoming atmosphere to enhance quality of service and care offered to patients and for respective provider(s) Assist physician in medical, cosmetic and laser procedures Assist provider in recording prescribed treatments, medications, biopsies, cultures, photos, prescriptions, prior authorization and procedures within established guidelines Understand provider to patient flow and anticipate provider's next steps to the best of their ability Prep rooms before and after patients, including checking all equipment at the beginning of each shift to ensure all is in proper working order Provide pre-care and post-care treatment instructions as needed Daily scan all retail and cosmetic products and medical supplies and alert Head MA and/or GM of any low level supplies Perform inventory responsibilities and stocking of supplies and equipment as requested Attend all in-house training and continued education opportunities Qualifications Dermatology experience preferred Healthcare experience required Nationally Certified Medical Assistant preferred Experience using EMR software and patient scheduling systems Must be computer savvy and familiar with Microsoft Word, Excel and Outlook Strong communication, interpersonal, and organizational skills Excellent patient relation and customer services skills Open availability to work during weekdays and weekends Hourly Pay Range $16-$21 USD Schweiger Dermatology Group, is an equal opportunity employer and does not discriminate in its hiring process with applicants, whether internal or external, because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender identity, disability, genetic information, veteran status, military status, application for military service or any other class per local, state or federal law. Schweiger Dermatology Group does not require vaccination for COVID-19 in order to be considered for employment; however, some state guidelines may require that we keep record of your vaccination status on file.

Posted 30+ days ago

S
Summit Health, Inc.East Hanover, NJ
About Our Company We're a physician-led, patient-centric network committed to simplifying health care and bringing a more connected kind of care. Our primary, multispecialty, and urgent care providers serve millions of patients in traditional practices, patients' homes and virtually through VillageMD and our operating companies Village Medical, Village Medical at Home, Summit Health, CityMD, and Starling Physicians. When you join our team, you become part of a compassionate community of people who work hard every day to make health care better for all. We are innovating value-based care and leveraging integrated applications, population insights and staffing expertise to ensure all patients have access to high-quality, connected care services that provide better outcomes at a reduced total cost of care. Please Note: We will only contact candidates regarding your applications from one of the following domains: @summithealth.com, @citymd.net, @villagemd.com, @villagemedical.com, @westmedgroup.com, @starlingphysicians.com, or @bmctotalcare.com. Job Description The Patient Service Representative (PSR) is responsible for welcoming and providing exemplary customer service to all our incoming patients at CityMD. The person in this position is responsible for registering patients and coordinating with the rest of the team to provide a timely turnaround for the patient. This individual responds to patient questions and concerns with a sense of urgency and kindness, both on the telephone and in person and is responsible for all paperwork associated with patient registration. Essential Functions/Responsibilities Greeting and welcoming patients Organizing and coordinating patient in-take and other appointments Accurately enters/updates patient information in system Assisting patients with completion of paperwork when necessary Scanning, updating and filing medical records Answering phone calls, questions, etc. in a prompt and polite manner Processing medical insurance information, verifying patient eligibility and addressing any patient questions about insurance (liaise with Billing department as appropriate) Handling cash and co-payments accurately and responsibly Providing outstanding customer service to every patient Informing site manager or assistant site manager of waiting room wait times, patient inquiries, etc. Qualifications A High School Degree or GED Happy, welcoming, and can-do attitude with patients and coworkers Experience working in any high-volume/high-intensity service industry (e.g., hospitality, restaurant, hospital, medical office or retail environment) preferred Excellent verbal, written, and interpersonal communication skills Detail-oriented and a team player Computer Proficiency and superior keyboarding skills (approximately 55 wpm) Flexible/adaptable nature to work in a continuously evolving environment Passion for helping others in a healthcare environment Ability to effectively interact with physicians, patients and other staff members Bilingual language skills required or preferred based on site location. Physical requirements Ability to sit and stand for periods of time. Heavy computer use required. #INDPSRRN Pay Rate: $18.25 per hour The provided compensation amount is based on industry standards and salary determinations will be made based on numerous factors including but not limited to years of experience and location of position. About Our Commitment Total Rewards at VillageMD Our team members are essential to our mission to reshape healthcare through the power of connection. VillageMD highly values the critical role that health and wellness play in the lives of our team members and their families. Participation in VillageMD's benefit platform includes Medical, Dental, Life, Disability, Vision, FSA coverages and a 401k savings plan. Equal Opportunity Employer Our Company provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to, and does not discriminate on the basis of, race, color, religion, creed, gender/sex, sexual orientation, gender identity and expression (including transgender status), national origin, ancestry, citizenship status, age, disability, genetic information, marital status, pregnancy, military status, veteran status, or any other characteristic protected by applicable federal, state, and local laws. Safety Disclaimer Our Company cares about the safety of our employees and applicants. Our Company does not use chat rooms for job searches or communications. Our Company will never request personal information via informal chat platforms or unsecure email. Our Company will never ask for money or an exchange of money, banking or other personal information prior to the in-person interview. Be aware of potential scams while job seeking. Interviews are conducted at select Our Company locations during regular business hours only. For information on job scams, visit, https://www.consumer.ftc.gov/JobScams or file a complaint at https://www.ftccomplaintassistant.gov/ .

Posted 1 week ago

Medical Assistant 2, Cast Tech-logo
Yale UniversityMilford, CT
Working at Yale means contributing to a better tomorrow. Whether you are a current resident of our New Haven-based community- eligible for opportunities through the New Haven Hiring Initiative or a newcomer, interested in exploring all that Yale has to offer, your talents and contributions are welcome. Discover your opportunities at Yale! Hourly Range 31.05 Overview Performs duties that support patient care including cast application, cast removal, autoclave instruments, technical procedures, DME application and inventory, direct and indirect patient care. All essential activities that provide comprehensive care to patients and contribute to the efficient operation of the clinic. This position supports the Milford Orthopedics clinic at 48 Wellington Rd. Required Skills and Abilities 1. Demonstrated proficiency with medical assisting standards and principles including all casting procedures. Proven ability to apply or remove a variety of Durable Medical Equipment and provide patient education under the guidance of physician or licensed personnel. 2. Proven ability with operational processes in a medical setting (i.e. clinical data collection, phlebotomy, and assisting physician or license personnel with in-office procedures). 3. Demonstrate proficiency in cleaning and maintaining all clinic specialty equipment according to infection control standards and clinic procedures. 4. Demonstrated ability to generate trusting and supportive relationships with patients, families, staff and faculty. 5. Strong communication skills, professionalism, and reliability. Principal Responsibilities Maintains a comfortable, safe and clean environment adhering to environmental, health and safety standards. 2. Under the direction of the physician or other licensed personnel, applies, adjusts or removes various types of casts, splints and braces. 3. Ensures patient safety at all times by demonstrating proper use of equipment and application/removal techniques. 4. Fabricates and fits braces, standard and custom splints, crutches and other medical equipment according to protocol and physician direction. 5. Maintains par levels of inventory and stocks exam rooms, replenishes and orders supplies including linen as needed. 6. Responsible for maintaining, cleaning and sterilization of medical instruments using an autoclave. 7. Gives appropriate post exam instructions to patients as instructed by physician or other licensed personnel or written protocol. 8. Communicate all changes in patients' condition and problems beyond the scope and responsibility to physician or other licensed personnel. 9. When casting responsibilities are not needed, expected to perform routine work of C-Level Medical Assistant as needed. 10. Other duties as assigned. Required Education and Experience Four years of related experience, 2 years of direct casting experience Background Check Requirements All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website. Health Requirements Certain positions have associated health requirements based on specific job responsibilities. These may include vaccinations, tests, or examinations, as required by law, regulation, or university policy. Posting Disclaimer The hiring rate of a role is determined in accordance with the provisions outlined in the respective collective bargaining agreement. The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the position. Employees will be assigned specific job-related duties through their hiring department. The University is committed to basing judgments concerning the admission, education, and employment of individuals upon their qualifications and abilities and seeks to attract to its faculty, staff, and student body qualified persons from a broad range of backgrounds and perspectives. In accordance with this policy and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual's sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran. Inquiries concerning Yale's Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA). Note Yale University is a tobacco-free campus.

Posted 30+ days ago

CA Medical Professional RN-logo
Octapharma PlasmaFresno, CA
ESSENTIAL JOB FUNCTIONS: Evaluates Donor Eligibility Determines donor eligibility of new and return donors for plasmapheresis procedures and immunizations by conducting evaluations to ensure criteria of plasma donors are met and in accordance with SOPs, Food and Drug Administration (FDA), Clinical Laboratory Improvement Act (CLIA), and cGMP. May not fulfill Licensed Physician's responsibilities for selection of donors for RBC immunization programs. May not evaluate the eligibility for plasmapheresis of donors with abnormal medical/laboratory findings. Reviews informed consent forms for plasmapheresis and immunization. Includes explanation of procedures, potential adverse events, immunization schedules, possible antibody formation, and dose administration. Offering clear opportunity for donor to refuse participation. Performs medical history reviews and health assessments for donors. Maintains accurate and up-to-date Physician Communication Logs, in accordance with SOP. Understands and utilizes donor center's donor management system (NexLynk). Maintains Donor Center Compliance Uses SOPs to facilitate compliance with regulations. Complies with federal, state, local, and company-specific regulations related to quality of product, employee and donor safety, and the proper performance of day-to-day activities. Reviews donor management system (NexLynk) and/or immunization paperwork to ensure accuracy and completeness. Manages Donors Reviews accumulated data in a timely fashion to confirm eligibility and consults with donor center Licensed Physician, as needed. Classifies donors to appropriate program. Monitors donor reactions to plasmapheresis and documents accordingly. Provides appropriate medical care per SOP to donors if complications arise. Interacts with donor center Licensed Physician regarding ordering immunizations. May not order immunizations. Monitors donors for possible adverse reactions to immunization. Medical Professional may not fulfill Licensed Physician's responsibilities in RBC immunization programs. Performs duties for the Hyperimmune Program, if applicable, as described in SOPs. Reviews all normal and abnormal test results in donor management system (Nexlynk) to determine continued donor eligibility. Cannot reinstate donors who have been deferred due to an abnormal Serum Protein Electrophoresis (SPE). May not evaluate high-risk/known infectious donors. May only determine the continued eligibility for plasmapheresis of normal, healthy donors. Ensures confidentiality of employee, donor, and donor center records while performing all duties. Counsels donors with abnormal test results or eligibility concerns and defers them according to the donor deferral matrix. Refers donors to appropriate county/state health department or similar for follow-up and diagnostic testing, when applicable per SOP. Additional Responsibilities Train as a Donor Center Technician I, as outlined in the Donor Center Technician I job description. Acknowledgment and signature of the job description are required. Note: This requirement does not apply to exempt managers acting as Emergency MP's. Upon completion of initial training in your functional area, and where applicable: Responsible for mentoring and training Medical Professionals, able to drive training efficiencies to ensure timeliness and compliance as a Designated Trainer. Train as a QA Backup and perform related duties as required by business needs. Performs other job-related tasks as assigned. JOB SPECIFICATIONS: Graduate of a recognized healthcare-related educational program, such as Physician, Nurse (Licensed Practical Nurse or Registered Nurse). Certified/licensed as an emergency medical technician (EMT Basic, EMT 2-intermediate, or 3- advanced/paramedic, if allowable). Must work within the scope of the professional license/certification, as defined by the state in which the work is performed. Any specific state licensing requirements must be met per location. Alabama: Must always have a Licensed Practical Nurse or Registered Nurse on staff during plasmapheresis to supervise processes and procedures, but not staff, of the medical screening and/or donor floor areas, per state regulation. California: Must be Registered Nurse and be currently licensed in the state. Must be able to supervise processes and procedures, but not staff, of the medical screening and/or donor floor areas, per state regulation. New Jersey: Must be a Licensed Practical Nurse or Registered Nurse. Must always have a Registered Nurse or a Licensed Practical Nurse on staff during plasmapheresis to provide emergency care, per blood bank state regulation. Ohio: Must be an EMT-Intermediate, EMT-Paramedic, Licensed Vocational Nurse, Licensed Practical Nurse, or Registered Nurse. Must have at least one (1) RN, LPN, LVN, EMT-P, or EMT-I always present in the Donor Center during plasmapheresis to supervise processes and procedures, but not staff, of the donor floor area, per state regulation. Washington: Must be a Licensed Practical Nurse or Registered Nurse. Must always have a Registered Nurse on staff during plasmapheresis to supervise processes and procedures, but not staff, of the medical screening and/or donor floor areas, per state regulation. One (1)-year experience in the hospital, field care, or experience in a plasma center preferred. Everyone performing moderate complexity testing must possess a current license issued by the state where the donor center is located, based on any required state regulations. Must successfully complete training program and competency assessments using OPIapproved training modules or training curriculum. Must have excellent patient/donor assessment skills. Must be able to manage emergency situations in accordance with standard medical care practices. Maintain current and valid license and pass medical credential evaluation. Must maintain current cardiopulmonary resuscitation (CPR) certification. Must be highly organized and have attention to detail. Possess effective physical and clinical assessment skills customer service, and people management skills. Ability to understand and follow SOPs and protocols. Must possess basic computer knowledge and skills. Basic working knowledge of Microsoft Word and Excel preferred. Must be able to speak, read, write, and understand English. Demonstrate consistency and reliability (good attendance, punctuality, full effort throughout shift, flexibility with assigned schedule). Ability to work shifts consisting of day and evening hours, weekends, holidays and extended shifts on a frequent basis. The expected base pay for this position at hiring is $40.78 - $54.38 - $67.97. Please note this wage range reflects what Octapharma Plasma expects to pay for this position at the listed location as of the time of this posting. Individual base pay for a successful candidate within this range is determined by qualifications, skill level, experience, competencies and other relevant factors PHYSICAL REQUIREMENTS: Ability to sit or stand for extended periods. Always utilize all required and appropriate PPE (Personal Protective Equipment). Ability to tug, lift, and pull up to thirty-five pounds. Ability to bend, stoop, or kneel. Ability to perform precise tasks that require repetitive small motor skills, such as drawing blood for screening tests. Occupational exposure to blood-borne pathogens. Ability to view video display terminal less than 18" away from face for extended periods of time, up to four (4) hours at a time. Enter an environment with a temperature of -40C or colder according to Standard Operating Procedures. Occasional exposure to and handling of dry ice. Ability to use assistive devices if needed for mobility or communication. Physical ability to perform CPR and sufficient mobility to immediately assist in treatment of any adverse donor reactions.

Posted 30+ days ago

Medical Assistant I (Ma) Urogynecology-logo
St. Elizabeth HealthcareEdgewood, KY
Job Type: Regular Scheduled Hours: 40 Job Summary: Reports to the Practice Manager or Team Leader, the Medical Assistant provides clinical support to the physician and mid-level providers. The Medical Assistant provides instructions to patients as directed by the providers. The Medical Assistant is also responsible for compliance with all OSHA/CLIA and HIPAA regulations and ensuring completion of all duties vital to business operations. Job Description: BENEFITS: No Nights, Holidays, or Weekends. Exceptions include Urgent Care and After Hours Clinics Paid Time Off Medical, Dental, and Vision 403b with Match Opportunity for Career Growth DUTIES AND RESPONSIBILITIES: Escort patients to exam rooms, interview patients, measure vital signs, including weight, blood pressure, pulse, temperature, and document all information in patients chart. Document the appropriate patient history in patients chart. Provide clear direction to the patient, address patient concerns about the exam and document appropriately in-patient chart Prepare the patient for the exam Assist the provider(s) during the examination. Perform nursing procedures under the supervision of the providers. Provide instructions to patient under direction of the provider(s). Collecting/preparing laboratory specimens and performing basic laboratory tests. Preparing and administering medications as directed by the provider. Ensure all information is complete and accurate in-patient chart. Ensure completion of all forms vital to the revenue cycle (i.e. verification/clarification of orders, waivers for non-covered services, encounter form) Maintain adequate level of supplies in exam rooms and workstation Clean and disinfect exam rooms. Perform cleaning, maintenance, and/or sterilization of equipment and instruments. Report malfunction of equipment to appropriate supervisor. OSHA, CLIA and HIPAA compliance. Maintain all logs and required checks (i.e. refrigerator temperatures, emergency medications, expired medications, oxygen, cold sterilization fluid change, etc.) Assist with completion of patient requests. Take telephone messages and provide feedback and answers to patient/provider/pharmacy calls. Triage and process messages from patients and front office staff to providers. Completion of referral process/outpatient test scheduling, and precertification. Timely and accurate filing/distribution of all patient information. Interact with Central Billing Office as needed to resolve patient issues. If working as a scribe, will follow guidelines for scribing as described in the Scribe policy. Other duties as assigned by the Clinical Coordinator or Practice Manager. MA CLINICAL REQUIREMENTS: Requirements vary by practice and could include any or all of the following Obtaining vital signs (manual blood pressure, pulse, respirations, temperature) Assisting providers with exams and procedures Administering injections and immunizations Performing EKG and other essential laboratory procedures Collecting patient samples (fingerstick, throat/nose swabs, urine) Answer and triage patient phone calls and questions EDUCATION: Minimum: High School Diploma/G.E.D. Knowledge of Excel, Word, Outlook and PowerPoint YEARS OF EXPERIENCE: Must have one of the following: One year of experience as an MA or CNA or other allied health experience Completion of an MA Externship Completion of SEP MA Internship Completion of EMT Certification Program Degree in Health or Biological Sciences inclusive of hands-on clinical patient care activities LICENSES AND CERTIFICATIONS: Preferred: An approved credential, such as the CCMA, CMA, RMA, ARMA or EMT FLSA Status: Non-Exempt Right Career. Right Here. If you have a passion for taking care of the community and are interested in Healthcare, you will take pride in the level of care we provide at St. Elizabeth. We take care of patients and each other.

Posted 30+ days ago

Medical Assistant (Full-Time)-logo
Diana HealthSmyrna, TN
About Diana Health Diana Health is a high-growth network of modern women's health practices. We are on a mission to set a new standard of care that inspires, empowers, and supports women to live healthier, more fulfilling lives. We partner directly with hospitals and align incentives across stakeholders using integrated care teams, smart technology, and a designed care experience that is good for patients and good for providers. The result is an individualized, comprehensive care program that puts women in the driver's seat of their own health and provides them with the information and compassionate care they need to reach their health goals. We are an interdisciplinary team joined together by our shared commitment to transform women's health. Come join us! Role Description We are looking for a Medical Assistant passionate about delivering patient-centered care and supporting an interdisciplinary care team in a busy women's health practice. You will play a critical role in ensuring smooth day-to-day practice operations in addition to managing a range of clinical and administrative responsibilities. The ideal candidate is excited about the opportunity to deliver a clinically and operationally excellent and compassionate patient experience for women and their families. What you'll do Support provider workflows to ensure smooth operations, including: Room patients, including taking vital signs and ensuring intake information is correctly listed in patient charts Turnover rooms at the end of visits, including cleaning and sterilizing equipment after use Support providers during in-office gynecological procedures and exams Other clinical duties as requested Assist with drawing and interpretation of patient labs, including: Blood draws Point-of-care (POC) tests (e.g. UPT, COVID, influenza, glucose, etc.) Vaccine administration Support operational processes to ensure a clean and high-functioning space: Maintain clinical inventory list ensuring its up to date and we always have adequate medical supplies Stock exam rooms and procedure rooms with medical supplies, linens, etc. Support with medical records management Assist with light housekeeping duties Adhere to established practice policies and procedures and follow state and federal regulations Qualifications High School Diploma/GED 1+ years relevant experience in the healthcare field preferred CMA and phlebotomy certified Strong computer skills and familiarity with EMRs Benefits Competitive compensation Health; dental & vision, with an HSA/FSA option 401(k) Paid time off Paid parental leave About the greater Nashville area Nashville is a growing city with a vibrant arts culture, top ranked education programs, and incredible outdoor attractions. It is listed in the top 25 "Best Places to Live" and known for its friendly people and legendary food scene. Diana Health Culture Having a growth mindset and striving for continuous learning and improvement Positive, can do / how can I help attitude Empathy for our team and our clients Taking ownership and driving to results Being scrappy and resourceful

Posted 30+ days ago

Medical Director-logo
PacificSourceHelena, MT
Looking for a way to make an impact and help people? Join PacificSource and help our members access quality, affordable care! PacificSource is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status, such as race, religion, color, sex, sexual orientation, gender identity, national origin, genetic information or age. PacificSource values the diversity of our community, including those we hire and serve. We are committed to creating and fostering a work environment in which individual differences and diversity are appreciated, respected and responded to in ways that fully develop and utilize each person's talents and strengths. Under the leadership of the Senior Medical Director, the Medical Director is responsible for the management of the PacificSource Commercial, Medicare, and Medicaid Lines of Business. This position will work closely with the Vice Presidents of each Line of Business in addition to other internal and external stakeholders to both develop and support initiatives in support of our membership and provider partners. Essential Responsibilities: Review and make clinical determinations on coverage for pre- or post-service requests in accordance with evidence-based guidelines, CMS coverage guidelines to include the Medicare Benefit Policy Manual, National Coverage Determinations (NCD), and Local Coverage Determinations (LCD) in addition to internal PacificSource policies. The determinations include but may not be limited to physical health, behavioral health, and oral health. Collaborate with stakeholders across the organization to create and drive clinical and business strategies focused on improving clinical performance, member experience, trend management, and quality. Participate actively in various external and internal committee meetings as assigned. As requested, develop strategy and subsequently engage with regulatory entities to fulfill obligations and execute on contractual commitments associated with the line of business. Lead clinical activities connected to PacificSource's growth for each line of business and participate as a key leader. Participate in other clinical or administrative oversight, planning or management as designated from time to time. Work with the Senior Medical Director and the Chief Medical Officer on various projects as assigned. Coordinate business activities by maintaining collaborative partnerships with key departments. Actively participate in the organization as a team member and physician leader at all times. Understand and apply knowledge of risk adjustment and hierarchical condition categories as it relates to clinical documentation and willingness to engage in continuous improvement strategies. Supporting Responsibilities: Meet department and company performance and attendance expectations. Follow the PacificSource privacy policy and HIPAA laws and regulations concerning confidentiality and security of protected health information. Perform other duties as assigned. SUCCESS PROFILE Work Experience: At least five (5) years of clinical experience required. Leadership experience in health insurance, provider organization, or closely related experience strongly preferred. Significant senior management policy and decision-making experience, including developing and implementing management best practices preferred. Education, Certificates, Licenses: Doctor of Medicine (MD or DO) with an unrestricted license to practice medicine in in any of the four states (MT, ID, WA, OR), or be willing to apply for state licensure in one of these four states. Board certification recognized by American Board of Medical Specialties (ABMS) is preferred. Knowledge: Comprehensive knowledge of business principles and techniques of administration, organization, and management to include an in-depth understanding of the key business issues that exist in the healthcare industry. These include, but are not limited to, quality improvement including, Lean methodology, healthcare economics, personnel administration, financial and cost analysis, and trends in the healthcare industry. Excellent understanding of all areas of medical conditions, treatment, and care. Excellent understanding of the insurance industry and risk factors and how they relate to the PacificSource organization. Demonstrated skills with the following software: Microsoft word, PowerPoint, and Excel. Competencies: Authenticity Building Organizational Talent Cultivating Networks Customer Focus Empowerment/Delegation Emotional Intelligence Establishing Strategic Direction Optimizing Diversity Passion for Results Environment: Work inside in a general office setting with ergonomically configured equipment. Travel is required approximately 10% of the time. Skills: Accountable leadership, Business & financial acumen, Empowerment, Influential Communications, Situational Leadership, Strategic Planning Our Values We live and breathe our values. In fact, our culture is driven by these seven core values which guide us in how we do business: We are committed to doing the right thing. We are one team working toward a common goal. We are each responsible for customer service. We practice open communication at all levels of the company to foster individual, team and company growth. We actively participate in efforts to improve our many communities-internally and externally. We actively work to advance social justice, equity, diversity and inclusion in our workplace, the healthcare system and community. We encourage creativity, innovation, and the pursuit of excellence. Physical Requirements: Stoop and bend. Sit and/or stand for extended periods of time while performing core job functions. Repetitive motions to include typing, sorting and filing. Light lifting and carrying of files and business materials. Ability to read and comprehend both written and spoken English. Communicate clearly and effectively. Disclaimer: This job description indicates the general nature and level of work performed by employees within this position and is subject to change. It is not designed to contain or be interpreted as a comprehensive list of all duties, responsibilities, and qualifications required of employees assigned to this position. Employment remains AT-WILL at all times.

Posted 30+ days ago

Certified Medical Assistant CMA - Northeast Georgia Physicians Group Ngpg - Family Health - Lab Specific - FT Days-logo
Northeast Georgia Health SystemBethlehem, GA
Job Category: Physician Services / Physician Clinics Work Shift/Schedule: 8 Hr Morning - Afternoon Northeast Georgia Health System is rooted in a foundation of improving the health of our communities. About the Role: Job Summary The Certified Medical Assistant (CMA) plays a crucial role at NGHS by providing both clinical and administrative support to medical professionals. Responsibilities entail a mix of patient care, clerical duties, and assisting practitioners with medical procedures. This position requires certification and often involves working in various healthcare settings such as hospitals, private practices, and clinics. Minimum Job Qualifications Licensure or other certifications: Active Registry or Certification as a Medical Assistant through a recognized certification body. Current BLS certification required or must be obtained within 30 days of hire. Educational Requirements: High School Diploma or GED Minimum Experience: Other: Preferred Job Qualifications Preferred Licensure or other certifications: Preferred Educational Requirements: Preferred Experience: Other: Job Specific and Unique Knowledge, Skills and Abilities Strong interpersonal and communication skills Proficiency in medical terminology and procedures Ability to multitask and prioritize various responsibilities Attention to detail and accuracy Competency in using medical software and electronic health records Problem-solving skills and critical thinking Empathy and a patient-centered approach to care Essential Tasks and Responsibilities Taking patient histories and vital signs Preparing patients for examination Assisting physicians during exams and procedures Collecting and processing laboratory specimens Administering medications as directed by the physician Performing basic laboratory tests Instructing patients about medication and special diets Removing sutures and changing dressings Facilitating patient education and promoting health habits Greeting and assisting patients as they arrive Scheduling appointments and managing calendars Maintaining patient records and filing documents Managing correspondence and communication Coordinating referrals and follow-up care Ensuring compliance with healthcare regulations and policies Physical Demands Weight Lifted: Up to 50 lbs, Occasionally 0-30% of time Weight Carried: Up to 20 lbs, Occasionally 0-30% of time Vision: Moderate, Frequently 31-65% of time Kneeling/Stooping/Bending: Frequently 31-65% Standing/Walking: Frequently 31-65% Pushing/Pulling: Frequently 31-65% Intensity of Work: Occasionally 0-30% Job Requires: Reading, Writing, Reasoning, Talking, Keyboarding, Driving Working Conditions Certified Medical Assistants work in a dynamic and often fast-paced environment. They may be required to stand for long periods, move and lift patients, and handle stressful situations with professionalism and composure. The nature of the job involves direct patient interaction, which requires a high degree of empathy and patience. Working at NGHS means being part of something special: a team invested in you as a person, an employee, and in helping you reach your goals. NGHS: Opportunities start here. Northeast Georgia Health System is an Equal Opportunity Employer and will not tolerate discrimination in employment on the basis of race, color, age, sex, sexual orientation, gender identity or expression, religion, disability, ethnicity, national origin, marital status, protected veteran status, genetic information, or any other legally protected classification or status.

Posted 1 week ago

Medical Assistant-logo
American Family Care, Inc.Vancouver, WA
Benefits: 401(k) Bonus based on performance Dental insurance Health insurance Opportunity for advancement Vision insurance WE DO URGENT CARE DIFFERENTLY- Come See How! Welcome to AFC Urgent Care Camas -- a Brand New, Beautiful Clinic where we're flipping the script on healthcare culture! Think supportive teammates, open leadership, and real opportunities to grow. Whether you're a seasoned Medical Assistant or just getting started, if you're passionate about helping people and want to make a difference -- this is the place! WHY YOU'LL LOVE IT HERE A Culture That Actually Cares: teammates who've got your back, leaders who listen, and zero bureaucracy. We believe in collaboration, not competition! Team Performance Bonus: when the clinic thrives, you share in the success! Monthly performance bonuses = more than just a pat on the back Learn. Grow. Level Up: want to expand your skills? We offer in-house Limited Scope Radiography (LXMO) training, with state certification costs fully covered! WHAT YOU'LL DO Be the right hand to our providers - assist in procedures and deliver exceptional care Own the triage process: take vitals, assess needs, and help patients feel at ease Show off your clinical skills: draw blood, give vaccines, run drug screens, and set up EKGs like a pro Dive into occupational health services and physicals - from start to finish Keep patient records sharp and up-to-date in our EMR system (we use Experity) Keep the clinic humming by stocking supplies and prepping equipment Make sure everything's running smoothly with daily checks on meds, supplies, and sterilization logs Be a key communication bridge - help patients get the info they need, fast Flex your versatility by jumping in at the front desk when needed (scheduling, check-ins, insurance) Be ready for anything - pitch in where needed and grow while doing it! SCHEDULES THAT WORK FOR LIFE Full-Time ~36-40 hours/week. Set shifts = no guessing game Choose one of two consistent schedule blocks: Front Half Team: Sun 9a-6p | Mon-Tue 8a-7p | Wed 8a-2:30p Back Half Team: Wed 1p-7p | Thu-Fri 8a-7p | Sat 9a-6p Just one on-call shift per month (and you get to choose the day!) LOCATION AFC Urgent Care- Camas 180 NE 192nd Ave #505, Vancouver, WA 98684 WHAT WE'RE LOOKING FOR We want driven, friendly, and detail-oriented Medical Assistants who bring positive energy and put patients first. Must thrive in a fast-paced setting and be willing to wear multiple hats. You'll Need: High School Diploma or GED WA State MA-C credential, required 1+ year experience in a medical office, preferred (urgent care experience is a bonus!) X-ray experience (RT or LXMO)? Even better! PAY & PERKS $22-28/hr (based on experience) $1,000 signing bonus! ($500 at 3 months, $500 at 1 year) Monthly team performance bonuses Free healthcare for you and your family through AFC 401(k) with 3% employer match after 1 year 3 weeks of paid time off On-the-job growth & training opportunities Supportive, non-toxic work culture that celebrates wins! OUR CORE VALUES Commitment- Commitments are clearly made and met Health- Healthy living for everyone is promoted through sustainable and responsible behaviors Excellence- Excellence in everything we do Celebrate- Celebrate wins - both small and large Trust- Trust builds teamwork through vulnerability and respect READY TO APPLY? If you want to grow your medical career while being part of something real, apply now and let's chat! SAFETY & WELLBEING Alcohol and Drug-Free Policy: We are an alcohol and drug-free workplace. Offers are contingent on the successful completion of background checks and drug screenings. EEO: AFC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Compensation: $22.00 - $28.00 per hour PS: It's All About You! American Family Care has pioneered the concept of convenient, patient-centric healthcare. Today, with more than 250 clinics and 800 in-network physicians caring for over 6 million patients a year, AFC is the nation's leading provider of urgent care, accessible primary care, and occupational medicine. Ranked by Inc. magazine as one of the fastest-growing companies in the U.S., AFC's stated mission is to provide the best healthcare possible, in a kind and caring environment, while respecting the rights of all patients, in an economical manner, at times and locations convenient to the patient. If you are looking for an opportunity where you can make a difference in the lives of others, join us on our mission. We invite you to grow with us and experience for yourself the satisfying and fulfilling work that the healthcare industry provides. Please note that a position may be for a company-owned or franchise location. Each franchise-owned and operated location recruits, hires, trains, and manages their own employees, sets their own employment policies and procedures, and provides compensation and benefits determined by that franchise owner. Company-owned locations provide a comprehensive benefits package including medical, dental, vision, disability, life insurance, matching 401(k), and more. We are an Equal Opportunity Employer.

Posted 30+ days ago

Medical Surgical Float Registered Nurse - RN - 24-H Nights-logo
Tufts MedicineLowell, MA
Why join our float pool? Float within specialty to increase your skills Newly increased differentials, applicable for all shifts Work fewer weekends and holidays! Tufts Medicine has a new Community RN Career Pathway plan that allows you to grow with us, no matter where you are in your nursing journey. This plan provides Lowell General Hospital nurses with a roadmap for compensation and purposeful professional development based on their experience and career aspirations. Job Summary: Lowell General Hospital is an outstanding place to work and offers amazing advancement opportunities for our staff. We have competitive salaries & benefits, shared governance, tuition reimbursement, clinical mobility tracks and free on-campus parking. Staff are encouraged to participate in our unit-based council or one of the many council opportunities. Unit Summary: The MedSurg Float Pool RN position is perfect for an RN who likes a fast-paced environment with an opportunity to learn and grow. MedSurg float RNs support medsurg and mixed acuity units, and float between the 2 Lowell General Hospital campuses (Main & Saints campus). MedSurg Float Pool RN positions offer a float pool hourly differential and requires two weekend shifts a month. Hours: 36 hours/week, OR 24/hours/week, Night Shift - Rotating Weekends and holidays! Qualifications: A minimum of 1-2 years in telemetry/Critical care is preferred Current RN licensure in the state of MA in good standing are required BSN is strongly preferred Associate's degree in nursing may be considered. Must enroll in BSN within year BLS required Specialized certifications preferred; PCCN or CVRN certifications What We Offer: Clinical Advancement Program which provides advancement opportunities and financial rewards Competitive salaries & benefits Paid certification and educational opportunities, including BLS, ACLS, CPI, ECCO CCRN review courses. 403(b) retirement plan with company match Shared governance, where nurses are encouraged to participate in unit-based councils or one of the many other council opportunities Tuition reimbursement Clinical mobility tracks Free on-campus parking Magnet Designation: The American Nurses Credentialing Center (ANCC) honored Lowell General Hospital with Magnet Recognition for excellence in nursing care with our 3rd designation achieved in August 2020. The Magnet Recognition Program recognizes healthcare organizations that are dedicated to nursing excellence, professionalism and patient-focused care. It is the highest level of recognition an organization can receive for providing the very best quality in patient care. Only 2% of hospitals have attained a 3rd Magnet designation. About Lowell General: For more than 125 years, Lowell General has served the Greater Lowell community with pride. We balance the first-rate care of a premier medical center with the warmth of a three-time Magnet-recognized community hospital. As a member of our team, you'll join over 3,000 dedicated care providers to offer complete, connected care, when and where patients need it most. Tufts Medicine is a leading integrated health system bringing together the best of academic and community healthcare to deliver exceptional, connected and accessible care experiences to consumers across Massachusetts. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network. We are an equal opportunity employer and value diversity and inclusion at Tufts Medicine. Tufts Medicine does not discriminate on the basis of race, color, religion, sex, sexual orientation, age, disability, genetic information, veteran status, national origin, gender identity and/or expression, marital status or any other characteristic protected by federal, state or local law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation by emailing us at careers@tuftsmedicine.org.

Posted 30+ days ago

Medical Receptionist - Primary Care - Walnut Creek - Full Time - 8 Hour - Days-logo
John Muir HealthWalnut Creek, CA
Job Description: Greets and directs patients and visitors in the medical office reception area, as well as accepts, screens and routes incoming calls. Collects payments and is responsible for demographic updates on patient information and insurance information. Education: High School Graduate or Equivalent Preferred Experience: 1 year Clerical- Front Office Required Certifications/Licensures: Epic- Proficiency must be passed within 90 days of Start Date Required work shift: 730-430 Work Shift: 08.0 - 7:30 - 16:30 No waive (United States of America) Pay Range: $24.75 - $33.40 Hourly Offer amounts are based on demonstrated/relevant experience and/or licensure. Pay will be adjusted to the local market if hired outside of the Bay Area. Note: Positions at JMH which are exempt (not eligible for overtime) under the level of Manager are listed as hourly for compensation purposes on this posting. The work shift will contain the word 'exempt' on it. Scheduled Weekly Hours: 40

Posted 1 week ago

Registered Nurse - New Grad - St. Rita's Medical Center-logo
Mercy HealthLima, OH
Thank you for considering a career at Mercy Health! Scheduled Weekly Hours: 36 Work Shift: All Work Shifts (United States of America) 2024/2025 New Grad RNs Positions available on Med Surg, Stepdown & ICU Full-Time Days or Nights Sign On Bonus up to $10,000 Can make offers up to 6 months prior to graduation! Summary of Primary Function/General Purpose of Position Delivers patient care utilizing the nursing process through data collection and assessment, identifies and determines the priority of patient's problems/needs, and evaluates the process and outcome of nursing care; coordinates, provides and directs patient teaching activities and coordinates the care provided by health team members. Essential Job Functions In collaboration with the interdisciplinary care team, conducts initial and ongoing patient assessment, analyzes assessment data, creates a plan of care, implements treatment and evaluates treatment effectiveness; administers medications in a safe manner consistent with the State of Ohio Nursing Practice Act and Mercy Health policies and procedures; serves as point of contact for patients' care coordination throughout hospital departments Acts as a patient safety advocate by participating in ongoing quality improvement in the department Incorporates the professional practice model into care delivery Employment Qualifications Education Qualifications- List the minimum education, training, and experience required to perform the essential functions of the position. Required Minimum Education: 2 Year/ Associates Degree Specialty/Major: Nursing Preferred Education: 4 year/ Bachelors Degree Specialty/Major: Nursing Licensing/ Certification- If registration, certification or licensure is required, include the name of the accrediting or licensing body. Licensure/Certification Required: Current nursing license in the State of Ohio and/or Kentucky or obtains RN license within 90 days of hire; Basic Life Support (BLS) - American Heart Association (preferred, not required); If licensure requirement is not met due to OBN failure, license must be obtained within 60 days of fail date Licensure/Certification Preferred: Hold national certification in clinical specialty or leadership within 6 months of eligibility Minimum Qualifications Minimum Years and Type of Experience: Other Knowledge, Skills and Abilities Required: This position requires the incumbent to demonstrate proficiency in clinical skills for patients in identified disease-specific and age-specific populations served, understanding that departures from identified categories may be required at times to perpetuate positive clinical outcomes Other Knowledge, Skills and Abilities Preferred: Mercy Health is an equal opportunity employer. Many of our opportunities reward* your hard work with: Comprehensive, affordable medical, dental and vision plans Prescription drug coverage Flexible spending accounts Life insurance w/AD&D Employer contributions to retirement savings plan when eligible Paid time off Educational Assistance And much more Benefits offerings vary according to employment status. Department: It is our policy to abide by all Federal and State laws, as well as, the requirements of 41 CFR 60-1.4(a), 60-300.5(a) and 60-741.5(a). Accordingly, all applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, age, genetic information, or protected veteran status, and will not be discriminated against on the basis of disability. If you'd like to view a copy of the affirmative action plan or policy statement for Mercy Health- Youngstown, Ohio or Bon Secours- Franklin, Virginia; Petersburg, Virginia; and Emporia, Virginia, which are Affirmative Action and Equal Opportunity Employer, please email recruitment@mercy.com. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact The Talent Acquisition Team at recruitment@mercy.com.

Posted 1 week ago

Medical Assistant - Credentialed For Center For Advanced Surgery In NE Portland-logo
The Oregon ClinicPortland, OR
Make an Impact at The Oregon Clinic! Premium Benefits, Competitive Pay, and Inspiring Purpose Join us at The Oregon Clinic as a full-time Credentialed Medical Assistant. Work alongside a collaborative team of patient-focused colleagues and physicians in our thriving Center for Advanced Surgery- East Clinic located in Northeast Portland. Each patient receives the highest value care tailored to their needs. Every person at TOC makes a difference in our mission of delivering world-class care with kindness and empathy. As a member of our team, you have the opportunity to make a valuable impact within the local community and our ecosystem of care. By providing patients and internal and external stakeholders with a consistent, efficient, and easy experience, you'll help ensure that patients at The Oregon Clinic Center for Advanced Surgery- East Clinic receive the highest value care tailored to their needs. Using excellent customer service and communications skills, your primary duties in this role include: Responsible for assisting the medical staff by collecting information, escorting patients to exam rooms, and preparing patients for examination. Assisting with procedures and performing specialty-related tests/monitoring. Scheduling appointments for established patients as needed. Ordering labs as needed. Obtaining completed imaging as needed. Sending Referrals to other specialists as needed. Updating records as needed. Assisting with the overall delivery of patient care in the department. Other duties as assigned. Salary: Hiring range, based on experience and credentials: Level I: $24.18-$32.72 per hour. Level II: $26.60-$35.99 per hour. Level III: $29.26-$39.59 per hour. Workdays: This role is primarily located at the Providence Cancer Center, with occasional coverage at the Center for Advanced Surgery- West Clinic located at the Providence St. Vincent Medical Center East Pavilion. Typical hours are Monday-Friday, (8:30 am- 5:00 pm). Qualifications that support success in this role are based on education, experience, and values including: Minimum of one (1) year of previous experience as a Medical Assistant is strongly preferred. Specialty Care experience is a plus! Certification through a national agency such as AAMA, NCCT, etc. is required. Current CPR/BLS within 60 days of hire. ACLS may be required by specialty. Prior Electronic Medical Record (EMR) experience is strongly preferred. Epic experience is a plus! Excellent attendance and work ethic. Positive attitude and desire to be a team player. Ability to communicate professionally and effectively with patients, physicians and other team members. A commitment to patient-focused care, privacy, and safety. This description is intended to provide only basic guidelines for meeting job requirements. Responsibilities, knowledge, skills, abilities and working conditions may change as needs evolve. Make an impact in patient-focused healthcare. Look forward to coming to work and feel good about the work you do - apply today! Premium Benefits: Healthcare: Employee is 100% covered Medical, Dental, Vision, and Prescription Insurance Financial Wellbeing: Generous 401(k) plan and Flexible Spending Account options Work-Life Balance: Paid Time Off plus 8 paid holidays annually Wellness Support: Robust wellness program and employee assistance services Commuter Benefits: 70% of Tri-Met transit pass covered Additional Perks: Employee discounts and optional benefits like Pet Insurance Patients and peers recognize The Oregon Clinic as a top regional healthcare provider and employer. We are: Guided by our values of dedicating to excellence, compassionate and joyful connection, inclusive collaboration, listening humbly, and leading with integrity. The largest physician-owned, multi-specialty medical and surgical practice in Oregon with a team of 1,500 team members across 30 specialties and our business office. Dedicated to providing the highest value care tailored to the needs of each unique patient. Proud to be consistently ranked by our employees as a Top 10 Workplace by The Oregonian. Our Commitments: Diversity, Equity, & Inclusion: We are more than an Equal Opportunity Employer. We welcome and embrace differences and a diversity of backgrounds. Our goal is for patients, physicians, and team members to see and feel diversity, equity, safety, and inclusion in all aspects of their interactions with TOC clinics and administration. A safe workplace: We are an alcohol and drug-free workplace for the safety of our patients and employees. Offers are contingent on successful completion of drug and background screenings.

Posted 1 week ago

A

Regulatory Affairs Specialist - Medical Devices

Anteris Technologies Global CorpMaple Grove, MN

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Job Description

Anteris is a science-driven structural heart company that is redefining expectations and advancing the field through cutting-edge solutions focused on restoring native-like physiology versus treating symptoms of structural heart disease. We are currently developing a new class of TAVR designed to mimic the performance of a healthy aortic valve. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.

Reporting to the Director of Regulatory Affairs, the Regulatory Affairs Specialist will lead and execute regulatory submission and approval activities for the company's medical device products, with a primary focus on U.S. FDA submissions. This role will also provide support for international regulatory submissions outside North America. The Specialist will coordinate with FDA and international regulatory bodies throughout the submission and review processes to ensure timely approvals and ongoing compliance with applicable regulations and corporate standards.

In addition, this role will support regulatory aspects of clinical studies. This position will contribute to a collaborative team environment with the unique opportunity to directly impact our mission, vision, and values as we take the company to the next level of success.

At Anteris, you'll be part of a high-caliber team advancing a transformative therapy for aortic stenosis. We value accountability, objectivity, respect, teamwork, integrity, and courage, and we're united by a shared purpose: improving patient lives through disruptive innovation. We're building something remarkable-and we're just getting started.

This role may be filled at varying levels, e.g., Senior or Principal, depending on the candidate's previous experience.

Key Responsibilities

  • Drive regulatory planning and execution to ensure alignment with business and functional goals and priorities
  • Prepare and review FDA submissions and other regulatory documents including 510(k)s, PMAs, PMA Supplements, PMA Amendments, Investigational Device Exemptions (IDE), Humanitarian Device Exemptions (HDE), Humanitarian Use Device (HUD) Applications and periodic study reports as assigned
  • Actively engage as the Regulatory Affairs representative on project teams
  • Serve as a liaison with the Regulatory Agencies globally by conducting negotiations with agency reviewers as needed
  • Review and interpret regulatory requirements as they relate to company products and procedures, clinical studies, testing or records keeping and ensure that they are communicated through company policies and procedures
  • Document review and approval to assure regulatory compliance (manufacturing process and product, change order, promotional review)
  • Ensure that regulatory requirements are fully understood, implemented and/or mitigated in new product, clinical, marketing, and other business processes
  • Communicate regulatory strategies and project status to internal stakeholders (Clinical Affairs, R&D, Marketing, Quality, Manufacturing)
  • Interact with and influence external regulatory agencies and trade associations
  • Author, review, and/or approve internal operating procedures related to regulatory affairs.
  • Coordinate timely renewal of certificates, licenses, and global product registrations.
  • Support Quality Assurance in maintaining ISO/CE Mark certifications and related regulatory audits.
  • Participate in complaints process in assessing and reporting to appropriate agencies

Skills, Knowledge, Experience & Qualifications

  • Bachelor's degree in science or engineering required. Advanced degree is a plus.
  • Minimum of 5 years of experience in Regulatory Affairs; 8+ years' experience preferred
  • Minimum of 5 years' medical device industry experience including Pre-Sub, IDE, 510(k), De Novo, PMA, Technical File/Design Dossier, and HDE submissions.
  • Experience with Global Regulatory Agencies (Notified Bodies, Competent Authorities, Health Canada, TGA) preferred.
  • Class III medical devices experience required; cardiovascular experience preferred. Experience with tissue heart valves is a plus.
  • Working knowledge of FDA requirements, guidance documents, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
  • Good understanding of product development process and design control through knowledge of US FDA and international medical device regulations
  • Must have ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully and professionally with all levels of personnel.
  • Strong interpersonal, analytical, writing, and organizational skills, including the ability to find creative regulatory solutions in "grey" areas.
  • Demonstrated ability in project management skills to plan, conduct and implement system assessments and robust submissions
  • RAC Certification preferred.

What We Offer:

  • Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
  • Collaborative and dynamic work environment with a culture of innovation and excellence.
  • Competitive compensation package, including salary, performance-based bonuses, and stock options.
  • Career development opportunities and a chance to be part of a growing company that values its employees.

Health and Wellness Offerings

  • Medical, Dental, and Vision Plans
  • Flexible Spending Account (FSA)
  • 401k + Company Match
  • Life, AD&D, Short Term and Long-Term Disability Insurance
  • Bonus Plan Eligibility
  • Employee Equity Program
  • Paid Holidays & PTO
  • Employee Assistance Program
  • Inclusive Team Environment
  • Job Types: Full-time, Contract

Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.

Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.

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