Senior Supervisor, Post-Market Surveillance & Clinical Follow-up

CONMED Corporation • Largo, FL

6d • $78,200 - $121,200 • Remote

About The Position

The Senior Supervisor, Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF), provides operational leadership, technical oversight, and people development for a team of Post-Market Surveillance Specialists supporting global medical device regulatory requirements. This role ensures the timely development, review, approval, and maintenance of PMS and PMCF deliverables, including PMS Plans, PMS Reports (PMSRs), Periodic Safety Update Reports (PSURs), PMCF Plans, and PMCF Evaluation Reports.
The Senior Supervisor serves as a senior departmental subject matter expert for PMS and PMCF activities and provides direct oversight of PMCF study execution from protocol development through study completion. This includes surgeon and investigator engagement, recruitment follow-up, contract and budget oversight, study monitoring, data evaluation, and final reporting.
This role requires advanced knowledge of global post-market surveillance requirements, strong analytical and statistical skills, demonstrated success with EU MDR compliance, and a proven track record of PMS and PMCF deliverables accepted by EU MDR Notified Bodies.

Requirements

• Bachelor's degree in Life Sciences, Clinical Research, Nursing, Public Health, or a related field.
• 3 to 4 years of experience as a Senior PMS Specialist, Lead PMS Specialist, Supervisor, Team Lead, or equivalent advanced role with clinical and post-market deliverable responsibility.

Nice To Haves

• Minimum of 5 years of experience in Post-Market Surveillance, Clinical Affairs, Clinical Research, Regulatory Affairs, Medical Writing, or a related medical device discipline, with demonstrated hands-on experience supporting or managing clinical studies.
• Current Good Clinical Practice (GCP) training or ability to complete GCP training within the onboarding period.
• Human Subject Protection / clinical research ethics training, if required for assigned PMCF study responsibilities.
• Documented training or equivalent demonstrated competency in EU MDR PMS and PMCF requirements, ISO 14155, ISO 14971, and applicable company procedures.
• Preferred professional certifications include CCRP, CCRA, RAC, RCC-MDR, or other relevant clinical research, regulatory affairs, or medical device compliance credentials.
• Demonstrated experience authoring, reviewing, and/or approving PMS Plans, PMSRs, PSURs, PMCF Plans, and PMCF Evaluation Reports.
• Demonstrated hands-on experience supporting clinical study execution, including protocol development, investigator or site engagement, recruitment tracking, study documentation, budget or contract coordination, data review, and final reporting.
• Experience analyzing and interpreting clinical and post-market surveillance data.
• Demonstrated experience supporting EU MDR compliance activities and Notified Body reviews.
• Proven history of PMS or PMCF deliverables accepted or approved by EU MDR Notified Bodies.
• Prior clinical study management or clinical research experience strongly preferred, particularly experience supporting medical device studies, PMCF studies, registry activities, or post-market clinical evidence generation from planning through final reporting.
• Equivalent combinations of relevant clinical research, medical device, PMCF, PMS, regulatory, or Clinical Affairs experience may be considered in lieu of a degree.
• Industry certifications such as CCRP, CCRA, ACRP-CP, RAC, or RCC-MDR are highly desirable.

Responsibilities

• Provide day-to-day leadership, mentoring, training, and performance support for a team of three Post-Market Surveillance Specialists.
• Review, provide feedback, approve, and sign final PMS and PMCF deliverables, including PMS Plans, PMSRs, PSURs, PMCF Plans, and PMCF Evaluation Reports.
• Oversee execution of PMCF studies, including protocol development, surgeon/investigator recruitment, site follow-up, study progression monitoring, contract coordination, and budget tracking.
• Analyze and interpret post-market clinical, safety, complaints, vigilance, literature, registry, and trend data to support benefit-risk conclusions and regulatory reporting.
• Partner cross-functionally with Clinical Affairs, Regulatory Affairs, Quality, Medical Affairs, Risk Management, Legal, Procurement, Finance, and R&D to support global compliance and product lifecycle activities.
• Support audits, inspections, regulatory authority requests, and EU MDR Notified Body reviews related to PMS, PMCF, and post-market clinical evidence.
• Support development and execution of PMCF strategies in collaboration with Clinical Affairs leadership.
• Author, review, and maintain PMCF study protocols, study plans, data collection tools, and supporting clinical study documentation.
• Identify, recruit, and maintain relationships with surgeon investigators and clinical study sites.
• Conduct investigator discussions and maintain ongoing communication to support recruitment, enrollment, follow-up, and study progression.
• Monitor study enrollment, milestones, deliverables, timelines, and overall study performance.
• Track study budgets, review expenditures, and help ensure PMCF studies remain within approved budget parameters.
• Create, coordinate, and oversee investigator agreements and study-related contracts in collaboration with Legal, Procurement, Finance, and other applicable functions.
• Coordinate internal and external stakeholders to support successful study execution and timely completion of PMCF objectives.
• Monitor ongoing PMCF studies and proactively identify and escalate risks related to timelines, data quality, recruitment, budget, or study deliverables.
• Support study analysis, interpretation of results, and preparation of final PMCF reports.
• Perform critical review and interpretation of post-market clinical and safety data.
• Apply statistical and analytical methodologies to assess product performance, safety, clinical outcomes, and benefit-risk profiles.
• Translate complex clinical, safety, and post-market data into clear regulatory conclusions.
• Maintain awareness of evolving global regulatory requirements impacting PMS, PMCF, and post-market clinical evidence activities.
• Support continuous improvement initiatives related to PMS and PMCF processes, templates, systems, and quality expectations.

Benefits

• Competitive compensation
• Excellent healthcare including medical, dental, vision and prescription coverage
• Short & long term disability plus life insurance -- cost paid fully by CONMED
• Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
• Employee Stock Purchase Plan -- allows stock purchases at discounted price
• Tuition assistance for undergraduate and graduate level courses
• Employee Referral Program incentives

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level