Medical Device Specialist – QA & Regulatory

About the role

We are seeking a Medical Device Specialist to support both Quality Assurance and Regulatory Affairs for medical devices and in‑vitro diagnostic products. The position is remote, lasts 12 months, and may require occasional travel to Belgium, Italy and Turkey.

Key responsibilities

• Maintain and improve the Quality Management System (QMS) and associated SOPs.
• Participate in internal audits and support external audits conducted by Notified Bodies.
• Manage CAPAs, change controls, complaint handling and batch release documentation.
• Conduct supplier evaluations, qualification and audit activities.
• Support CE‑marking activities, prepare and maintain technical files for devices and IVDs.
• Develop and update GSPR checklists, risk‑management plans, analyses and reports.
• Contribute to clinical‑evaluation documentation and post‑market surveillance (PMS plans, PSURs, PMCF reports).
• Respond to regulatory queries from EU and international distributors and assist with product registrations outside the EU.

Required profile

• Scientific degree in Life Sciences, Biomedical Engineering, Pharmacy or related field.
• Minimum 3 years of experience in medical devices and/or IVDs, covering both QA and RA.
• Fluency in English and French, with strong written communication skills.
• Ability to manage multiple priorities in an international environment.

Required skills

• In‑depth knowledge of EU MDR and IVDR requirements.
• Experience with technical documentation and Quality Management Systems.
• CAPA and change‑control management.
• Risk‑management planning and execution.
• Supplier auditing and qualification.