Senior Regulatory Affairs and Quality Assurance Engineer
- International company
- Medical devices
Senior Regulatory Affairs and Quality Assurance Engineer
Our client is an international company specialized in medical devices.
Description
- 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.
Profile
- 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.
Job Offer
Great opportunity to join an amazing team and work on challenging projects.
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