Senior Regulatory Affairs and Quality Assurance Engineer

vor 2 Wochen


Lausanne, Schweiz Michael Page Switzerland Vollzeit
  • 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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