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    Regulatory Affairs Associate - Santa Clara, United States - GForce Life Sciences

    GForce Life Sciences
    GForce Life Sciences Santa Clara, United States

    4 weeks ago

    GForce Life Sciences background
    Description
    Regulatory Affairs Associate – Santa Clara, CA
    MUST BE ABLE TO WORK ON A W2


    Job Summary:


    The Regulatory Affairs Compliance Support role is pivotal in ensuring adherence to regulatory standards by providing crucial support to the Regulatory Affairs (RA) organization.

    The position involves driving key performance indicator (KPI) dashboards, managing strategic programs for RA audit preparedness, supporting quality system integration for acquisitions and new product introductions, and implementing system and/or systemic processes.

    The role also includes tracking and maintaining regulatory post-approval commitments and driving quality system process improvement initiatives.


    Responsibilities:
    Drive preparation of KPI dashboards and maintain a pulse on formal RA management review and internal metrics.
    Manage strategic programs for RA audit preparedness, including identifying and mitigating risks, and implementing preventive actions.
    Support quality system integration for acquisitions and new product introductions.
    Identify and implement system and/or systemic processes.
    Support tracking and maintenance of regulatory post-approval commitments.
    Drive quality system process improvement initiatives.
    Establish audit support for integration products.
    Improve and maintain quality system procedures (e.g., change management).
    Liaise with cross-functional partners and international affiliates to meet audit compliance needs and drive implementation/resolution.
    Participate in audit backrooms.
    Participate in RA projects.
    Investigate nonconformances (CAPAs) and implement mitigations (potential).


    Qualifications:


    Experience in Medical Device US and CE regulations, Quality Systems, a Quality role, or a Compliance role is a plus.

    Independent with strong troubleshooting skills.
    Critical thinker with the ability to drive problems through resolution and implement mitigations.
    Ability to handle multiple streams simultaneously.

    Term & Start
    6 month contract
    FT, M-F 40hr/week

    Pay Rate:
    $45-50/HR ($90-100K Annually)

    Onsite in Santa Clara, CA

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