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.