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

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 REMOTE 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.

Key Responsibilities

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Provide day-to-day leadership, mentoring, training, and performance support for a team of three Post-Market Surveillance Specialists.

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Review, provide feedback, approve, and sign final PMS and PMCF deliverables, including PMS Plans, PMSRs, PSURs, PMCF Plans, and PMCF Evaluation Reports.

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Oversee execution of PMCF studies, including protocol development, surgeon/investigator recruitment, site follow-up, study progression monitoring, contract coordination, and budget tracking.

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Analyze and interpret post-market clinical, safety, complaints, vigilance, literature, registry, and trend data to support benefit-risk conclusions and regulatory reporting.

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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.

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Support audits, inspections, regulatory authority requests, and EU MDR Notified Body reviews related to PMS, PMCF, and post-market clinical evidence.

PMCF Study Oversight

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Support development and execution of PMCF strategies in collaboration with Clinical Affairs leadership.

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Author, review, and maintain PMCF study protocols, study plans, data collection tools, and supporting clinical study documentation.

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Identify, recruit, and maintain relationships with surgeon investigators and clinical study sites.

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Conduct investigator discussions and maintain ongoing communication to support recruitment, enrollment, follow-up, and study progression.

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Monitor study enrollment, milestones, deliverables, timelines, and overall study performance.

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Track study budgets, review expenditures, and help ensure PMCF studies remain within approved budget parameters.

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Create, coordinate, and oversee investigator agreements and study-related contracts in collaboration with Legal, Procurement, Finance, and other applicable functions.

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Coordinate internal and external stakeholders to support successful study execution and timely completion of PMCF objectives.

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Monitor ongoing PMCF studies and proactively identify and escalate risks related to timelines, data quality, recruitment, budget, or study deliverables.

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Support study analysis, interpretation of results, and preparation of final PMCF reports.

Data Analysis and Regulatory Compliance

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Perform critical review and interpretation of post-market clinical and safety data.

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Apply statistical and analytical methodologies to assess product performance, safety, clinical outcomes, and benefit-risk profiles.

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Translate complex clinical, safety, and post-market data into clear regulatory conclusions.

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Maintain awareness of evolving global regulatory requirements impacting PMS, PMCF, and post-market clinical evidence activities.

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