Quality MDR Specialist
Role Details
Contract: 12 months
Location: Ile-de-France, France - Hybrid (around 80% onsite presence required)
Start date: ASAP
Languages: French (required) & Professional English
Key Responsibilities
- Support the ongoing MDR transition within the Quality team
- Lead or contribute to risk assessments aligned with MDR requirements
- Provide expert guidance on sterilisation processes and related documentation
- Manage interactions and responses with Notified Bodies
- Support remediation and V&V activities (approx. 20%)
- Review and update QA documentation, guidance, and procedures
- Collaborate closely with cross‑functional teams (RA/QA, R&D, Operations, Project teams)
- Provide knowledge transfer and training to the internal team to ensure smooth handover at the end of the contract
- Contribute as a senior, hands‑on Quality professional to strengthen overall MDR compliance
Requirements
- 8+ years' experience in Quality Assurance within the medical devices sector
- Deep, practical expertise in MDR regulations
- Masters in engineering, pharmaceuticals or other related fields.
- Strong background in sterilisation, risk management, remediation, and V&V
- Proven experience working with Notified Bodies
- Pragmatic, hands‑on approach with strong communication skills
- Fluent in French and English
- Able to integrate quickly and provide senior support to an existing team
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