Senior Regulatory Affairs and Quality Assurance EngineerMichael Page

Our client is an international company specialized in medical devices.

• Technical documentation writing management (for Europe & the US);
• Involvement in the development and design of the company's medical devices;
• Risk management, from the early life of each device;
• Review and approval of validation and verification documents;
• Acting as Process Owner;
• Contribution to internal & external audits;
• Ensure strong collaboration with other teams, and supporting them in QA/RA trainings.

• Minimum 3 years of experience within the medical device industry;
• Strong knowledge of ISO 13485, ISO 14971, 21 CFR, MDR;
• Experience with submitting technical files for Europe & the US;
• French and English are mandatory.