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    Sr. RA Specialist - Indiana, United States - Intuitive

    Intuitive
    Intuitive Indiana, United States

    3 weeks ago

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    Description
    Job Description

    Primary Function of Position

    The Senior Regulatory Affairs Specialist serves as the primary regulatory lead on projects involving complex electromechanical, software controlled robotic systems, instruments and accessories, SaMD and advanced imaging systems.

    The Sr.

    RA Specialist works across the organization and liaises with global regulatory counterparts on a wide range of products including capital equipment, instruments and accessories (single use or re-usable), and software, focusing on supporting ongoing changes and continuous improvement to these products.

    Essential Job Duties
    Support product engineering and manufacturing teams on regulatory issues, including review of design input, risk management and test documentation
    Evaluate changes to products including changes to design, material, labeling, packaging, manufacturing process, and facility
    Assess the impact of the product/process changes and determine regulatory pathway for US markets
    Present regulatory strategy and status in internal group settings
    Gather information from international counterparts for ROW regarding the impact of changes and work with international counterparts to coordinate global regulatory submissions/approvals
    Prepare internal documentation, and prepare and submit regulatory filings including non-filing justifications (NFJ) and 510(k)s
    Provide oversight of third party agency testing (UL, EMC, biocompatibility, sterilization) as required
    Perform other duties as required

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