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