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Laguna Woods

    Sr. Regulatory Affairs Specialist - Laguna Woods, United States - BioTalent

    BioTalent
    BioTalent Laguna Woods, United States

    4 days ago

    Default job background
    Description
    Position

    Summary

    The primary responsibility of the Senior Regulatory

    Affairs Specialist is to manage and perform regulatory submissions for local

    and worldwide regulatory agencies. The Sr. RAS is also responsible for ensuring

    products and procedures comply with regulatory agency specifications. Supports

    necessary regulatory activities required for product market entry and

    maintenance. The position requires a high level of innovative thought and

    problem-solving skills. Multiple tasks will need to be prioritized and

    responsibilities delegated to ensure department success. In addition to the above

    responsibilities, the regulatory specialist is required to interact with

    multiple departments within the our clients organization as well as regulatory

    bodies.

    Duties and


    Responsibilities:

    • Develops strategies and implements plans to
    obtain FDA Approvals, CE Mark and other foreign regulatory approvals.


    • Prepare regulatory submissions and
    registrations (FDA and EU regulatory entities)


    • Support IDE, PMA, 510(k), Design Dossiers,
    Technical Files, and other regulatory filings.


    • Maintain regulatory Technical Files, Device
    Master Records, Essential Requirements Checklist, Risk Analysis, and Design

    History Files.


    • Review changes to Existing Products, SOPs,
    DOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field

    issues to define the requirements for regulatory submissions and notifications.


    • Support communication with FDA and Notified
    Body representative while preparing responses to deficiency letters and/or

    questions from regulatory agencies.


    • Represent Regulatory Affairs on Engineering
    & R&D product development project teams to ensure all regulatory

    requirements are met throughout the development process.


    • Perform additional duties as required

    REPORTING
    This position will report directly to the VP,

    Quality and Regulatory Affairs. Our clients Specific duties will be determined

    and coordinated in conjunction with the corporate needs and strategic plans and

    will be subject to change given ongoing business and clinical research needs.


    JOB

    QUALIFICATION REQUIREMENTS

    • Bachelor's degree (B.S.) from four-year
    College or University.


    • Three (4) years minimum experience in
    regulatory affairs.


    • Current knowledge of FDA Guidelines, Medical
    Device Directives (93/42/EC), ISO 13485, and standards applicable to company

    products.


    • Knowledge and understanding of Quality and
    Regulatory concepts and application


    • Strong analytical, planning and
    organizational skills


    • Strong interpersonal and communications
    skills (oral & written)


    • Self-starter with ability to work
    independently under pressure and react quickly to changing priorities


    • Proficient in MS Office products.
    #J-18808-Ljbffr
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