Post-Market Surveillance Consultant
Post‑Market Surveillance Consultant (Medical Devices)
Location: Eindhoven, Netherlands
Contract length: 12 months
Engagement: Freelance / Contract
Key Responsibilities
- Lead and execute Post‑Market Surveillance activities in compliance with EU MDR 2017/745.
- Develop, maintain, and update PMS documentation, including:
- PMS Plans
- PMS Reports (PMSR)
- Periodic Safety Update Reports (PSURs)
- Benefit‑risk analyses
- Manage vigilance activities, including complaint handling, trend reporting, and field safety corrective action (FSCA) assessments.
- Collaborate cross‑functionally with Quality, Regulatory Affairs, Clinical, and Risk Management teams.
- Ensure timely monitoring of field data, clinical literature, and regulatory intelligence.
- Support authority inspections, audits, and internal assessments.
- Work with external partners and notified bodies as needed.
Required Experience
- Minimum 3-5 years experience in Post‑Market Surveillance within the medical device industry.
- Strong knowledge of EU MDR, ISO 13485, ISO 14971, and vigilance reporting requirements.
- Experience preparing PMSRs and PSURs.
- Background in working with Class II or Class III medical devices (preferred).
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