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    Principal Regulatory Affairs - San Diego, United States - Insight Global

    Insight Global
    Insight Global San Diego, United States

    4 weeks ago

    Insight Global background
    Description
    An employer is looking for a Principal Regulatory Affairs team member. This member would be responsible for 510K submissions and be responsible for developing regulatory strategies, preparing U. S. and major market submissions and obtaining approval to introduce new spinal implants and human tissue products worldwide. This role would heavily support New Product Development for US, EU, and International product launches.

    They will do the preparation of regulatory submissions such as US pre-submissions, 510(k)s, IDE, and Letter-to-File submissions for new products and product changes as required to take products to market.

    The candidate will work on reg submissions for Class II and Class I product changes - Biologics and Bone Graft products.

    They will maintain proficiency in worldwide regulatory requirements. Provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring FDA/govt approval.

    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day.

    We are an equal opportunity/affirmative action employer that believes everyone matters.

    Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.

    If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to .

    com.

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    Regulatory 510K experience for Biologics (bone grafts) and orthopedic devices


    • Advanced degree in a scientific/Regulatory affairs discipline (engineering, physical/biological or health sciences)
    • 5 years of medical device regulatory affairs experience with Master's degree
    • Bachelors degree in a related discipline
    • Minimum of 7 years of regulatory affairs experience
    • Regulatory experience submitting Class II 510Ks over the last 2 years (needs to be current with the new regulatory experience needed)
    • Has been the lead on a Class II/Class IIA regulatory submission (Mechanical/Biologics for Ortho Med Device preferred)
    • Strong expertise in all aspects of Regulatory Affairs; Strategy Planning, Submission Prep, US and major market regulatory requirements, project management, and negotiations
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