Senior Project Manager Clinical Evaluation

Job Description Senior Project Manager, Clinical Evaluation

The function of a Clinical Evaluation Report Project Manager supporting our Structural Heart Clinical Evaluation Products combines understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with the European Commission Guidelines on Medical Devices: Clinical Evaluation : A Guide for Manufacturers and Notified Bodies under (MEDDEV 2.7/1 Rev 4) and EU Regulation 2017/745.

The CER PM is recognized as a subject matter expert for guidelines and regulationsregardingthe clinical evaluation process and its consequent documents (e.g., CEP, PMS/PMCF Plan, SSCP and PSUR, and CER). As such, this person has oversight of one or more medical writersguidingthe development, or update, of CERs and CER-related documents. In addition, the CER PM will interact cross-functionally with various personnel toidentifyand obtain relevant documentation and data on safety, performance, adverseeventsand risk/benefit profile of a device ordevices. Moreover, the CER PM may be requested to contribute to other activities such as risk assessment and management, and review of informational documents like the Instructions for Use. The CER PM will sit on core team product development, CER-related SOPdevelopmentand revision, and interact with regulatory agencies’ representatives as needed.

The role of PM plays a significant part in new product development, as well as in thesubsequentevaluation of the safety and performance of a device over its lifecycle. The position reports to the Sr. Manager of Clinical and Risk Evaluations.

Main Responsibilities:

• Manage medical writers’ efforts in writing and editing of scientific content of deliverables, and the timelines of these documents

• Creates, manages, orparticipatesin timelines of deliverables by usingappropriate projectmanagement tools.

• Clearly andtimelycommunicates the timelines, project risks, and risk mitigation strategies with cross functional teams and medical writers

• Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice

• Write and edit, as needed, Clinical Evaluation Plans and Clinical Evaluation Reports, and other clinicalCER  deliverables.

• Participate in and/or lead the development of regulatory responses for Notified Body questions upon review of submissions.

•  Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D, Clinical R&D, Sales and Marketing, Library Services, Quality Engineering, Clinical Affairs, Risk Management, Project Management, as well as external vendors such as CROs, Medical Writers and Reviewers).

• Providestrategic guidance on regulatory requirementspertaining toclinical data and clinical evaluation to new product development teams and sustaining teams.

• Participate in and support audits and responses to audit findings asappropriate, in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics.

• Function independently as a decision-maker on CER-related regulatory issues and mustassurethat deadlines are met.

• Execute projects within budgetary guidelines.

Required Qualifications:

• BachelorsDegree (± 16 years),in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fieldsis preferred.

• Minimum2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or relatedarea

• Minimum3-4years experiencein a regulated industry (e.g., medical products,nutritionals). Note: Higher education may compensate for years of experience.

• Regulatory history, guidelines, policies, standards, practices,requirementsand precedents

• Regulatory agency structure,processesand key personnel

• Principles and requirements of applicable product laws

• Submission/registration types and requirementsGxPs(GCPs, GLPs, GMPs)

• Principles and requirements of promotion,advertisingand labeling

• International treaties and regional, national,localand territorial trade requirements,agreementsand considerations

• Domestic and international regulatory guidelines,policiesand regulations

• Ethical guidelines of the regulatory profession, clinicalresearchand regulatory process

• Regulatory history, guidelines, policies, standards, practices,requirementsand precedents

• Regulatory agency structure, processes and key personnel Principles and requirements of applicable product laws

• Submission/registration types and requirements

• GxPs(GCPs, GLPs, GMPs)

• Principles and requirements of promotion,advertisingand labeling

• International treaties and regional, national,localand territorial trade requirements,agreementsand considerations

• Domestic and international regulatory guidelines,policiesand regulations

• Ethical guidelines of the regulatory profession, clinicalresearchand regulatory process

• Pay strong attention to detail

• Manage project

• Create project plans and timelines

• Think analytically

• Organize and track complex information

• Exercise judgment within broadly defined practices and policies in selecting methods,techniquesand evaluation criteria for obtaining results

• Has broad knowledge of various technical alternatives and their potential impact on the business

• Exercise good and ethical judgment within policy and regulations

• Use in-depth knowledge of business functions and cross group dependencies/ relationships Define regulatory strategy with supervision Follow scientific arguments,identifyregulatory scientific data needs and with supervision solve regulatory issues

Preferred Qualifications:

• A college degree (Bachelor’s) isrequired;  inthe life sciences (nursing, medicine, biomedical engineering)

• Experience writing CERs and related documentsin accordance withMEDDEV 2.7/1 Rev 4 and MDR submissions

• 3-5+ years of experience in clinical research, quality systems, or regulatory experience in medical device

• Understanding of regulations, standards and guidelines related to medical devices clinical studies, and quality systems, MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485

• Effective written, verbal and presentation skillsin the area oftechnical/clinical applications

• Strong command of medical and surgical terminology

• Project management and/or management of people experience

• Demonstrated ability toidentifyand adapt to shifting priorities and competing demands

• Highly developed interpersonal skills, and strong attention to detail with accountability for ensuring deliverables are met on time

Post graduate degree (Masters or Doctorate) preferred in the life sciences (nursing, medicine, biomedical engineering)

• Experience in structural heart / structural intervention devices

• Certification is a plus (e.g., RAC and PMP)

• MD / PhD/RN/Pharm D with good written skills