• Regulatory Affairs Associate - exp

    Job Location(s) US-NJ-Mahwah
    Posted Date 2 months ago(2 months ago)
    Job ID
    2018-29655
    Category
    Medical Services
    Position Type
    Contract (Full-Time)
    # of Openings
    1
  • Overview

    The Sr. Regulatory Affairs Specialist works with direct supervision to bring medical devices to market and ensure ongoing compliance while continuing to develop their regulatory skills. Participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review labeling and marketing materials, and evaluate proposed device changes.

    Qualifications

    • 3+ years of experience within medical device or other regulated industry
    • Knowledge of FDA Quality System Regulations (21 CFR), EU Medical Device Directives (MDD), and applicable guidance documents.
    • Experience with additional international regulations preferred.
    • 510(k), Letter-to-File, CE Technical File/Design Dossier preparation, review, and submission experience.
    • Understanding of the FDA device listing and establishment registration process.
    • Demonstrated abilities and skills in the following key areas:
    • Analytical and writing skills -Organizational and planning skills
    • Advanced PC skills (MS Outlook, Word, PowerPoint, Excel)
    • Interpersonal communication, collaborative team work, and negotiation skills
    • Complying with constantly changing regulatory procedures; reprioritizing work effectively
    • Identifying and correcting errors and inconsistencies (e.g. grammatical, contextual, etc.)
    • Rapidly building product knowledge and understanding of highly technical and scientific regulatory activities

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