About the job
We are looking for Quality & Regulatory Affairs to join our team and support key projects related to regulatory compliance and quality assurance. This position is designed for professionals with a strong motivation for the regulatory field of medical device software.
Main responsibilities:
- Quality Management System (ISO 13485): Maintenance of the QMS, document control, support during internal and external audits, monitoring of quality KPIs, non-conformities (NCs), and CAPA activities.
- Medical software (IEC 62304): Support in software verification and validation activities, including documentation review, test execution, traceability, records, and evidence generation.
- Technical Documentation (IVDR): Participation in the preparation of deliverables for software as an IVD (GSPR, risk management, V&V;, SVR, labeling) and their integration into the Technical Documentation.
- Laboratory environment (ISO 15189): Involvement in the creation and update of procedures and records related to clinical laboratory operations.
- Cross-functional operational support: Management of platform-related incidents, support in responding to technical customer inquiries (under supervision), and other transversal tasks according to team priorities.
Set yourself apart
What we value:
- Real interest in Medical Device Regulations (IVDR/MDR), software as a medical device (IEC 62304), and risk management (ISO 14971).
- Strong technical writing skills, organization, and attention to detail.
- Technical English (reading and writing).
- Proficiency with office software and collaborative tools.
- Proactive attitude, curiosity, and willingness to learn in a highly regulated environment.
What's on offer?
Fagron is a young, professional, dynamic, and ambitious company with plenty of growth opportunities. We offer a unique working environment where talent and ambition can develop to their fullest. We have an open and informal organization culture, where you need to be able to work independently.
- Competitive salary
- Social benefit
- Meals
- Hybrid model: 2 days Home Office
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