PMS Complaint Handling Specialist

The Post-Market Surveillance & Complaint Handling Specialist is responsible for managing complaint handling and post-market surveillance activities to ensure product safety, regulatory compliance, and continuous product improvement. The role combines complaint investigation, complaint process ownership, vigilance reporting support, trend monitoring, and preparation of post-market surveillance documentation.

Your role:

• Investigate customer complaints, adverse events and product performance issues.
• Perform complaint intake review, duplicate assessments, coding verification and root cause investigations.
• Execute Good Faith Efforts (GFEs) and document investigation outcomes.
• Oversight of complaint handling quality, compliance and process improvement activities.
• Monitor complaint trends, product performance data and safety signals.
• Support vigilance reporting and regulatory submissions.
• Prepare and maintain PMS Plans, PMS Reports and supporting documentation.
• Support audits, inspections and regulatory compliance activities.
• Collaborate with Quality, Regulatory Affairs, Clinical, R&D, Manufacturing and Markets.

You're the right fit if you have:

• Bachelor degree in Medical Sciences, Healthcare Management, Engineering, Quality, Life Sciences or equivalent.
• 3-5 years of experience in Medical Devices, Complaint Handling, Quality Assurance, PMS, Regulatory Affairs or equivalent.
• Affinity and/or experience with medical device regulations and standards.
• Strong understanding of complaint handling, PMS and regulatory requirements.
• Good communication and influencing skills in English and preferably basic knowledge of the Dutch language.
• Ability to work in-office at least 3 days per week.