Jobs

    Regulatory Affairs Specialist - Carlsbad, United States - Atec Spine

    Atec Spine
    Atec Spine Carlsbad, United States

    1 week ago

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    Description


    ATEC Spine has an exciting opportunity for a Regulatory Affairs Specialist to work on-site at our location in San Diego, California.

    The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products; as well as the support of daily activities related to product design teams, change control, and regulatory product submissions.

    Essential Duties and Responsibilities

    • Collaborates as a core team member on new product development teams. Determines and documents appropriate regulatory strategy for proposed new products. Supports design control activities.
    • Supports and assists in FDA 510(k) premarket notifications and ROW regulatory submissions.
    • Coordinates responses to regulatory agencies as part of the submission and approval process.
    • Evaluates design changes to products to determine impact to submissions and potential need for additional submissions.
    • Assists with post-market surveillance evaluation, trending, and reporting, including updates to risk management (FMEA) process.
    • Reviews and approves labeling and promotional materials for compliance with applicable regulations and policies.
    • Researches sources of regulatory information (e.g., regulatory agency websites, standards organization websites, literature, trade sheets, competitor information, etc.).
    • Provides department support during internal and external audits.
    • Develops and maintains procedures and/or work instructions for product registrations.
    • Maintains FDA establishment listings and registration.
    • Other duties as assigned.
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