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    Regulatory Specialist - Santa Clara, United States - INTELLECTT INC

    Intellectt Inc background
    Description
    Hi

    One of our medical clients is looking for the role

    Regulatory Specialist , if you are interested or your skills matches please share with me your updated resume


    Role:
    Regulatory Specialist


    Location:
    Santa Clara, CA

    Duration: 12 Months

    Job Description

    Support regulatory department for efficient and compliant processes.
    Execute tasks and collaborate across business functions and with suppliers.
    Assist in data collection for global product registrations.
    Prepare and submit registration documentation worldwide.
    Implement and maintain the effectiveness of the quality system.
    Support day-to-day manufacturing operations and change control.
    Provide regulatory advice for product development.
    Interpret and apply regulatory understanding to support products and teams.
    Prepare U.S. regulatory submissions and registration documents.
    Handle regulatory activities for documentation, labeling, and field support.
    Ensure compliance with quality systems and site/division-level policies.

    Requirements

    Education:
    BA Degree Required; Bachelor's degree in Science, Math, Engineering, or Medical Fields preferred.

    Experience: 2-5 years in regulatory affairs, 2 years in relevant industrial roles, and 3-5 years in Medical Device Regulatory Affairs.

    Skills


    Knowledge of IVDs and/or biologics regulations, EU MDR, regulatory change assessment, US and EU medical device submissions, cross-functional collaboration, and continuous improvement activities.

    #J-18808-Ljbffr

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