Post Market Surveillance Specialist

About the role

The Post Market Surveillance (PMS) Specialist ensures that Philips’ medical devices are continuously monitored for safety and regulatory compliance. The role works across business units to standardise PMS processes, support risk management and provide clinical input for regulatory reporting.

Key responsibilities

• Establish and maintain standard PMS processes, plans and reports across all product lines.
• Conduct proactive surveillance (regulatory database searches, literature reviews) and reactive surveillance (complaint handling, field actions).
• Collaborate with Medical Affairs to monitor safety signals, assess complaints and prepare regulatory submissions.
• Support risk management by defining risk acceptability criteria, overseeing post‑market risk assessments and health‑hazard evaluations.
• Provide governance for PMS and RM, ensuring consistent statistical trending and signal escalation.
• Represent PMS interests in multidisciplinary product development teams and ensure delivery of PMS/RM artefacts throughout design.

Required profile

• Bachelor’s degree in engineering or equivalent.
• 8‑10 years of experience in the medical‑device industry with a focus on post‑market surveillance.
• Strong knowledge of relevant regulations (ISO 13485, ISO 14971, FDA 21 CFR, EU MDR, etc.).
• Proficiency in English (written and spoken) and ability to communicate with regulatory authorities.

Required skills

• ISO 13485 compliance knowledge.
• ISO 14971 risk‑management expertise.
• Familiarity with FDA 21 CFR sections 803, 806, 822.
• Understanding of EU MDR requirements.
• Statistical analysis and trending techniques.
• Health‑hazard evaluation methodology.