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Alameda

    Regulatory Affairs Specialist - Alameda, United States - INTELLECTT INC

    INTELLECTT INC
    INTELLECTT INC Alameda, United States

    2 weeks ago

    Intellectt Inc background
    Description

    Role:
    Regulatory Affairs AssociateLocation: Alameda, CADuration: 10 + Months
    Shift Timings: 8 am to 5 pm

    Job Description:

    Experience in a medical device or similarly regulated industry Ability to schedule and organize multiple projects BS Engineering or Scientific Manager regulatory submissions to ensure timely regulatory approval of medical devices.

    Monitor changing regulations in geographies and translate/communicate these requirements to project development and/or continuous improvement project teams. Ensure all client products and procedures comply with applicable regulatory agency requirements and guidelines.

    Supports execution of External Regulations Standards and Guidance Documents packages through tracking and monitoring ePAS packages from draft to final closure Prepares metrics associated with the process for Executive Management Review (EMR) Completes final signature approval of an ePAS package (i.e., FSG Approval) Data review, analysis, and verification.


    Top 5 skills/requirements:
    Strong analytical and problem-solving skills. Demonstrated competency and working knowledge of Excel, Word, PowerPoint, SharePoint, and Teams. Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents. Ability to work with people from various disciplines and cultures. Strong attention to detail.

    Good organizational / project management skills to manage and track a wide range of tasks; ability to develop realistic action plans as well as prioritizing work activities.

    #J-18808-Ljbffr
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