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    Regulatory Affairs Specialist - Scarborough, United States - GForce Life Sciences

    GForce Life Sciences
    GForce Life Sciences Scarborough, United States

    3 weeks ago

    GForce Life Sciences background
    Description

    Regulatory Affairs Specialist II On-site in Scarborough, ME

    RESPONSIBILITIES

    • Implement & maintain the effectiveness of the quality system
    • Support manufacturing/operations day to day activities for change control
    • Assist regulatory specialist in change control- and product development-related duties
    • Provide regulatory assistance on team activities
    • Interpret and apply regulatory understanding to support of products and teams
    • Prepare U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide
    • Handle regulatory activities involved in documentation, labeling, and field support
    • Apply regulatory and technical knowledge to a wide variety of complex work assignments
    • Maintain and ensure compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports
    • Ensure compliance to and demonstrate knowledge of site- and division-level policies and procedures

    QUALIFICATIONS

    • Bachelors Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.
    • 2+ years experience in Regulatory Affairs role.
    • 1+ years experience in an IVD or medical device manufacturing environment.
    • Experience with quality systems and change control.
    • Knowledge of US FDA regulatory registrations/submissions.
    • Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio.

    TERM & START

    • On-site in Scarborough, ME
    • 6-month contract from 6/3-EOY
    • Pay Rate: Up to $40/hr ($80k annually)
    • FT hours, M-F 8a-5p
    • Business Unit: Infectious Disease
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