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Post Market Surveillance Manager

Laborie Medical Technologies CorpMinnetonka, Minnesota

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Job Description

We believe that great healthcare is an essential safeguard of human dignity.
At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.
 
We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.
 
Who We’re Looking For:
As a key member of the Clinical team, the Post Market Surveillance Manager will lead post-market activities for medical devices, ensuring compliance with global regulations. As a subject matter expert, the Post Market Surveillance Manager will own and oversee clinical evaluation and surveillance processes, manage documentation (CEP, PMS/PMCF Plans, SSCP, PSUR, CER), provide leadership and development to the team and collaborate cross-functionally to maintain safety, performance, and risk/benefit profiles for a diverse product portfolio.
 
About the Role:

Post Market Surveillance, Clinical Evaluation and Documentation:

  • Oversee timely completion of PMS Plans, Reports, CEPTs, CERs, PMCF Plans and SSCPs.
  • Author and maintain PSURs, PMS Plans/Reports, CEPs, CERs, SSCPs, and regulatory responses, integrating clinical, literature, and post-market data.
  • Conduct literature reviews and data analyses for regulatory submissions.
  • Partner and deliver with Regulatory Affairs, R&D, Quality, Clinical Affairs, and external stakeholders to develop evaluation strategies.

Project Management:

  • Manager medical writing schedules and ensure timely delivery of regulatory documents; communicate project timelines and risks to ensure completion.
  • Facilitate cross-functional collaboration and communication to meet project timelines and budget adherence.

Regulatory Compliance:

  • Ensure documentation meets standards for guidelines and within company procedures (e.g., ICH, FDA, EMA, EU MDD/MDR).
  • Support audits, corrective actions, notified body responses and quality metrics.

People Management:

  • Responsible for managing a team of internal and external medical writers including training, mentoring, development, and supervising of staff.
 
Minimum Qualifications:
  • Bachelor's degree in Science, Medical Technology or related field.
  • Minimum 8 years of relevant work experience in Clinical Research, R&D or Quality in medical devices, with at least 1 year in a leadership role.
  • Proven track record in authoring CERs, PMS Plans, PSURs, SSCPs, and PMCF per MEDDEV 2.7/1 Rev 4 and EU MDR.  
  • Strong analytical and problem-solving skills.
  • Excellent communication and project management skills. Proficiency in data metrics, complaint handling or device operations.
 
Preferred Qualifications:
  • Advanced degree in Science, Medical Technology or related field.
  • Knowledge of MDD93/42/EEC, MDR 2017/745, ISO 14971, ISO 14155, and ISO 13485.
 
Why Laborie:
Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.
  • Paid time off and paid volunteer time
  • Medical, Dental, Vision and Flexible Spending Account
  • Health Savings Account with Company Funded Contributions
  • 401k Retirement Plan with Company Match
  • Parental Leave and Adoption Services
  • Health and Wellness Programs and Events
  • Awarded 2024 Cigna Healthy Workforce Designation Gold Level
Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.
 

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