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    Senior Regulatory Affairs Specialist - Seattle, United States - Hobson Associates

    Hobson Associates
    Hobson Associates Seattle, United States

    1 week ago

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    Description

    Job Title:

    Senior Regulatory Affairs SpecialistLocation: Greater Seattle Area (Hybrid Role, Three Days In-Office)Our client is looking for a Senior Regulatory Affairs Specialist to become the newest member of our QA/RA Team located in the Seattle Area.

    The Senior Regulatory Affairs Specialist is an individual contributor responsible for creating and submitting 510(k) applications , including coordinating any pre-submissions and requests for additional information to obtain clearance.


    Principal Responsibilities:


    Serve as a core team member in cross-functional new product development teams, leading the development and execution of regulatory strategies in alignment with business objectives and regulatory requirements.

    Plan, develop, prepare, and obtain timely approval for product submissions, with focus on US FDA 510(k) applications.

    Ensure compliance with all applicable regulatory requirements governing products, with focus on US FDA.Train and mentor junior regulatory affairs team members.

    Provide regulatory advice for product design, manufacturing, enhancements, marketing advertising and promotional materials.

    Ensure compliance with internal procedures, applicable regulations, guidelines, local country registration requirements, with emphasis on FDA's Quality System Regulation for Design Control and labeling requirements.

    Provide clear and consistent regulatory guidance to facilitate timely delivery of leading-edge products and services to customers.


    Knowledge, Skills, and Abilities:


    Capable, confident individual contributor with 8+ years of experience with a Bachelors degree, 6+ years of experience with a Masters degree, or 3+ years of experience with a PhD.Working knowledge of all FDA submission requirements, including 510(k), Q-Submission, and associated guidance documents.

    Demonstrated experience in submitting and obtaining clearance with US FDA.Knowledgeable and skilled core team regulatory affairs representative to ensure regulatory requirements are fulfilled and adequate.

    Subject Matter Expert in design dossiers and design history file content to ensure design documentation is adequate to support regulatory submissions.

    Possess excellent situational influencing skills with ability to work effectively in cross-functional teams with R&D, quality, marketing, manufacturing, clinical, and other project team functions.

    Must have exceptional writing, verbal, and people skills with internal and external stakeholders.
    Maintain positive, collaborative relationships with all regulatory agencies.


    About Hobson Associates' Client:


    Our client is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility.

    The device family revolves around bladder volume measurement and airway management.#J-18808-Ljbffr
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