Regulatory Affairs Manager - Los Angeles - QuidelOrtho

    QuidelOrtho
    QuidelOrtho Los Angeles

    1 day ago

    Description

    Regulatory Affairs Manager

    QuidelOrtho is a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry, and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries.

    The Role

    • We're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Regulatory Affairs Manager. This role provides strategic and tactical regulatory leadership for the QuidelOrtho product portfolio, with a dedicated focus on Complex Systems including Physical IVD Instrumentation Embedded Software Software as a Medical Device SaMD Laboratory Automation Connectivity Informatics solutions.

    This includes leading regulatory impact assessments authoring high-quality global pre-market submissions ensuring compliance with evolving Cybersecurity Section 524B and global Digital Health mandates acting as a critical bridge between Commercial Marketing Technical R&D teams Global Regulatory Bodies to ensure seamless market access total lifecycle compliance.


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