Job Description COMPLAINT & PMS SPECIALIST – MEDICAL DEVICES WHAT YOU WANT TO KNOW • Salary: €42,000 – €55,000 • Working pattern: 3 days onsite / 2 days remote • Location: Soesterberg, Netherlands • Contract: Permanent • Department: Quality • Reporting to: QA/QC Manager JOB DETAILS Our client is an established medical device manufacturer operating within a highly regulated environment. They are seeking a Complaint & Post-Market Surveillance (PMS) Specialist to support and maintain compliant complaint handling and post-market processes aligned with ISO 13485, MDR and applicable international regulations This role plays a critical part in safeguarding product quality and regulatory compliance. You will manage complaint investigations, trend post-market data, drive CAPAs and contribute to risk management activities across the product lifecycle. The position suits someone detail-oriented, structured and confident working cross-functionally within Quality, Regulatory, R&D and Production teams. ROLES & RESPONSIBILITIES • Manage, investigate and close customer complaints in compliance with MDR and ISO 13485 • Evaluate and classify complaints, including escalation and vigilance decision-making • Collect, analyse and trend complaint and PMS data • Maintain PMS documentation including plans and reports • Support regulatory reporting activities (vigilance, adverse events, FSCA) • Participate in internal and external audits related to complaint and PMS processes • Initiate and manage CAPAs arising from complaint trends • Verify effectiveness of corrective actions • Contribute to product risk management file updates • Support cross-functional teams with complaint handling and quality awareness ESSENTIAL EXPERIENCE • Minimum 1 year experience within QA, Complaint Handling or PMS in Medical Devices • Strong working knowledge of ISO 13485 and MDR requirements • Experience working within a structured Quality Management System • Analytical mindset with attention to detail • Confident documentation and reporting skills • Fluent English (written and verbal) DESIRABLE • Exposure to PMCF or Clinical Evaluation activities • Experience supporting regulatory reporting submissions • Background in technical or scientific field