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).