Are you a proactive Quality & Regulatory Affairs Specialist ready to take ownership of product complaint handling, investigation, and CAPA within a regulated environment?
This role is ideal for someone who thrives on getting to the root of issues, driving supplier accountability, and ensuring products remain safe, compliant, and audit‑ready.
Tasks in the role include:
* Manage the full lifecycle of product complaints, from intake to closure
* Lead structured investigations and root‑cause analysis
* Communicate directly with suppliers, challenge investigation quality, and issue SCARs where needed
* Drive effective CAPA actions, ensuring timely implementation and robust effectiveness checks
* Maintain high‑quality documentation aligned with ISO 13485, MDR, MDSAP, FDA 21 CFR 820 or similar
* Support audits, trend analysis, and continuous improvement across the QMS
* Trained internal auditor would be an advantage
* Assist in Regulatory registrations, e.g. EUDAMED, MedEnvoy, etc
Required experience:
* Experience in Quality Assurance or Regulatory Affairs within a regulated industry
* Strong understanding of complaint handling, nonconformities, and CAPA
* Confident communicator able to work assertively with suppliers and internal teams
* Analytical mindset with excellent documentation skills
* Knowledge of ISO 13485, MDR and MDSAP frameworks
* Basic understanding of Technical File compilation
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