Director, Global Regulatory Affairs - Vancouver, WA - Calibre Scientific

    Calibre Scientific
    Calibre Scientific Vancouver, WA

    5 days ago

    $180,000 - $280,000 (USD) per year *
    Description

    Key Responsibilities: Global Regulatory Affairs Leadership
    Own and execute the global RA strategy supporting market access, product lifecycle, and long-term business growth. Lead preparation, approval, and maintenance of global regulatory submissions including Technical Documentation 510(k), CE marking UKCA international registrations.

    An individual in this role should have:

    • Bachelor's or Master's Degree;10 plus years of progressive RA/QA leadership experience in Medical Device Diagnostics and or IVDs.Expert knowledge of ISO 13485 IVDR MDR FDA QSRQMSR and global regulatory frameworks.Demonstrated success leading global QA teams managing multi-region portfolios.Proven experience influencing executive stakeholders leading organizational change
    * This salary range is an estimation made by beBee
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