Medical Device Specialist

We are looking for a Medical Device Specialist to join our team and support Quality Assurance and Regulatory Affairs activities for medical devices and in vitro diagnostic products. Remote | 12-month contract. The position may involve occasional travel to Belgium, Italy, and Turkey. Responsibilities: Quality Assurance (QA) - Support and maintain the Quality Management System (QMS) - Review, update, and manage Standard Operating Procedures (SOPs) - Participate in internal audits and support external audits conducted by Notified Bodies - Manage CAPAs, change controls, and complaint handling activities - Support batch release activities through documentary compliance reviews - Conduct supplier evaluations and support supplier qualification and audit activities - Ensure compliance with applicable quality standards and regulatory requirements Regulatory Affairs (RA) - Support CE marking activities for medical devices and IVDs - Prepare, update, and maintain Technical Documentation/Technical Files - Develop and maintain GSPR checklists - Support Risk Management activities, including plans, analyses, and reports - Contribute to Clinical Evaluation documentation (CEP, CER) - Support Post-Market Surveillance activities, including PMS Plans, PSURs, PMCF Plans, and Reports - Respond to regulatory requests from EU and international distributors - Support product registrations and regulatory submissions in non-EU markets Experience & Qualifications: - Scientific degree (Life Sciences, Biomedical Engineering, Pharmacy, or related field) - Minimum 3 years of experience in Medical Devices and/or IVDs - Experience in both Quality Assurance and Regulatory Affairs activities - Good knowledge of EU MDR and/or IVDR requirements - Experience with technical documentation and Quality Management Systems - Fluency in English and French - Strong writing, communication, and problem-solving skills - Ability to manage multiple priorities and work in an international environment