Medical Device Specialist (QA & RA) - Remote

About the role

ProductLife Group is looking for a Medical Device Specialist to support Quality Assurance and Regulatory Affairs activities for medical devices and in vitro diagnostic products. The position is remote on a 12-month contract, with occasional travel to Belgium, Italy and Turkey.

Key responsibilities

• Quality Assurance: support and maintain the Quality Management System (QMS); review, update and manage SOPs; take part in internal audits and support external audits by Notified Bodies; manage CAPAs, change controls and complaints; support batch release through documentary compliance reviews; evaluate suppliers and support their qualification and audits; ensure compliance with quality standards and regulations.
• Regulatory Affairs: support CE marking for medical devices and IVDs; prepare and maintain technical documentation and technical files; develop and maintain GSPR checklists; support risk management plans, analyses and reports; contribute to clinical evaluation documentation (CEP, CER); support post-market surveillance (PMS plans, PSURs, PMCF plans and reports); respond to regulatory requests from EU and international distributors; support product registration and regulatory submissions in non-EU markets.

Required profile

• Scientific degree (Life Sciences, Biomedical Engineering, Pharmacy or related field).
• At least 3 years of experience in medical devices and/or IVDs.
• Experience in both Quality Assurance and Regulatory Affairs.
• Fluency in English and French.
• Nice to have: previous experience supporting Notified Body audits, supplier auditing experience, and knowledge of international regulatory frameworks outside the EU.

Required skills

• Good knowledge of EU MDR and/or IVDR requirements.
• Experience with technical documentation and Quality Management Systems.
• Strong writing, communication and problem-solving skills, and ability to manage multiple priorities in an international environment.