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    Senior Regulatory Affairs and Quality Assurance Engineer - Lausanne, Schweiz - Michael Page Switzerland

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    Beschreibung
    • 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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