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Somerville

    Regulatory Affairs Consultant - Somerville, United States - Fladger Assoc. Inc.

    Fladger Assoc. Inc.
    Fladger Assoc. Inc. Somerville, United States

    1 week ago

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    Description

    Job Description

    Job DescriptionSomerville, NJContract Duration: 12 month unlimited extensionRate: Negotiable

    Responsibilities:

    • Excellent employment opportunity for a Regulatory Affairs Consultant in the Somerville, NJ area.
    • Represent Regulatory Affairs by attending project team meetings, providing regulatory strategies, reviewing project documentation, and participating in design control activities, as scheduled.
    • Prepare and submit product, manufacturing, packaging, or labeling changes to European Notified Body, based on project schedule
    • Prepare 510(k)'s to FDA pertaining to device changes requiring FDA clearance, based on project schedule
    • Submit notifications to company Regulatory Affiliates pertaining to changes to product, manufacturing, packaging, labeling, etc. and provide necessary documentation to country affiliates, based on project schedule.
    • Daily communication and meeting attendance with project teams, as scheduled
    • Daily or weekly communication with company Regulatory Management on project status and deliverables, as scheduled.

    Experience:

    • BS Degree
    • 3-5 years as a Regulatory Affairs professional working on medical device projects
    • Regulatory Affairs with Class I, II and III devices
    • Experience with complaint handling, international registration and 510k submission
    • Development of international and domestic regulatory submissions to the FDA and European Union Countries.
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