Medical Device Specialist

About the role

We are seeking a Medical Device Specialist to support Quality Assurance and Regulatory Affairs for medical devices and in‑vitro diagnostic products. The role is remote with occasional travel to Belgium, Italy and Turkey, and is offered on a 12‑month contract.

Key responsibilities

• Maintain and improve the Quality Management System (QMS), including SOP updates and internal audit participation.
• Manage CAPA, change control, complaint handling and batch release documentation.
• Conduct supplier evaluations, qualifications and audits.
• Support CE marking activities, prepare and maintain technical files and GSPR checklists.
• Assist with risk management, clinical evaluation documentation and post‑market surveillance deliverables.

Required profile

• Scientific degree in Life Sciences, Biomedical Engineering, Pharmacy or related field.
• Minimum three years of experience in medical devices and/or IVDs, covering both QA and regulatory affairs.
• Fluency in English and French.

Required skills

• In‑depth knowledge of EU MDR and IVDR requirements.
• Experience with Quality Management System administration and technical documentation preparation.
• Capability to manage CAPA, change control and supplier audit processes.