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
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
Nice to Have
Previous experience supporting Notified Body audits
Supplier auditing experience
Knowledge of international regulatory frameworks outside the EU

Work arrangement
Yes