Regulatory Affairs Consultant (Freelance - Medical Devices)
Regulatory Affairs Consultant (Freelance - Medical Devices)
Location: Grenoble, France (hybrid - on‑site presence with flexibility)
Contract Length: 12 months (strong likelihood of extension)
Start Date: May 2026
Key Responsibilities:
- Contribute to the definition and execution of EU MDR regulatory strategy for both new development and lifecycle products, including Class IIb medical devices under Regulation (EU) 2017/745.
- Own and update technical documentation (Technical File / Design Dossier) to support CE marking, NB questions, and ongoing compliance.
- Work closely with R&D, Clinical Affairs, Quality, and Engineering teams to ensure regulatory requirements are embedded early and pragmatically.
- Act as a hands‑on regulatory subject matter expert, providing guidance on MDR interpretation, classification, GSPR mapping, and change impact.
- Support Notified Body interactions, including preparation for reviews, responses to questions, and audit readiness activities.
- Contribute to regulatory inspections and external audits (ISO 13485, MDR), ensuring documentation and processes meet current expectations.
- Support global registration activities as required (e.g. EU, FDA interface, alignment with international submissions) and ensure activities comply with the Quality Management System.
Required Experience:
- Bachelor's degree (or equivalent) in Life Sciences, Biomedical Engineering, Chemistry, Biology, or a related scientific discipline.
- Proven Regulatory Affairs experience within medical devices, ideally within Grenoble or similar MedTech clusters.
- Class IIb device experience is essential; experience with implantable, high‑risk, or technically complex devices is strongly preferred.
- Previous consulting or freelance experience
- Working proficiency in English required; French is highly beneficial given the local ecosystem.
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