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

🔥 0 minutes ago

🐊 Florida – Remote

🐊 Florida – Remote

💵 $78.2k - $121.2k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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CONMED Corporation

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1970

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 Post-IPO Debt on 2022-05

Healthcare • Consulting • Logistics

CONMED Corporation is a global medical technology company that develops, manufactures, and sells surgical equipment and instruments specifically for Orthopedic, General, and Gastrointestinal (GI) surgery. The company focuses on innovation and has a wide range of products including surgical power tools, implants, electrosurgical units, and smoke evacuation solutions. Through its mission to support healthcare partners and improve patient outcomes, CONMED is dedicated to enhancing surgical efficiency and safety across various medical specialties.

📋 Description

• 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 PMCF studies from protocol development through completion, including recruitment, site follow-up, monitoring, contracts, budgets, data evaluation, and final reporting • 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 • Support audits, inspections, regulatory authority requests, and EU MDR Notified Body reviews • Develop and execute PMCF strategies, author study protocols and plans, and maintain data collection tools and clinical study documentation • Identify, recruit, and maintain relationships with surgeon investigators and clinical study sites • Monitor enrollment, milestones, deliverables, timelines, study performance, risks, data quality, recruitment, budgets, and contracts • Support study analysis, interpretation of results, final PMCF reports, and continuous improvement of PMS and PMCF processes and systems • Apply statistical and analytical methodologies to assess product performance, safety, clinical outcomes, and benefit-risk profiles • Maintain awareness of evolving global regulatory requirements impacting PMS, PMCF, and post-market clinical evidence activities

🎯 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 • 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 • 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 • Equivalent combinations of relevant clinical research, medical device, PMCF, PMS, regulatory, or Clinical Affairs experience may be considered in lieu of a degree • This position is not eligible for employer-visa sponsorship • Expected travel 0-20%

🏖️ 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