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    Sr. Specialist, Regulatory Affairs - Carlsbad, United States - Atec Spine

    Atec Spine
    Atec Spine Carlsbad, United States

    2 weeks ago

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    Description


    The Regulatory Affairs Senior Specialist will be responsible for providing regulatory support of spinal implant and instrument product launches for domestic and international countries; as well as the support of daily activities related to product design teams, design control, and regulatory product submissions.

    Essential Duties and Responsibilities


    Collaborates as a core team member on new product development teams of US Class II implants and Class I and Class II instruments.

    Independently determines and documents appropriate regulatory strategy for proposed new products. Supports design control activities. Prepares and acts as lead correspondent of regulatory submissions, including 510(k) premarket notifications for US FDA. Prepares regulatory submissions, including STEDs, EPCs, and DoCs, to support registration of products in Australia. Responsible for internal process improvements, data/metric evaluation, maintenance of databases, and public-facing information. Assists with post-market surveillance evaluation, trending, and reporting including updates to risk management (e.g., FMEA) process. Reviews product labeling and promotional materials to ensure consistency with regulatory approvals. 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.

    Assists in developing, maintaining, assigning, and tracking company Standard Operating Procedures (SOPs) to ensure compliance with applicable global regulatory requirements.

    Maintains FDA establishment listings and registration.

    Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations, 510(k)s, labeling and promotional materials, ISO 13485, ISO 14971, 21 CFR 820, global medical device registration, technical writing, and external standards.

    Other duties as assigned
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