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    Regulatory Affairs Compliance Specialist - Santa Clara, United States - INTELLECTT INC

    INTELLECTT INC
    INTELLECTT INC Santa Clara, United States

    1 day ago

    Intellectt Inc background
    Description

    Nice to meet you!



    We are looking for a dedicated professional to join our team as a Regulatory Affairs Compliance Specialist at Santa Clara, California.



    Job Role:
    - Providing compliance support to the Regulatory Affairs organization by driving preparation of KPI dashboards and managing strategic programs for RA audit preparedness.
    - Supporting quality system integration for acquisitions and new product introductions.
    - Identifying and implementing system/process improvements and tracking regulatory post-approval commitments.
    - Leading quality system process improvement initiatives and participating in RA projects.

    Key Responsibilities:
    - Establishing audit support for integration products.
    - Improving and maintaining quality system procedures.
    - Collaborating with cross-functional partners to meet audit compliance needs.
    - Investigating nonconformances (CAPAs) and implementing mitigations.

    Requirements:
    - Experience with Medical Device US and CE regulations, Quality Systems, or Compliance is a plus.

    Tasks Include:
    - RA Change Requests Tracking and Closure.
    - Developing and implementing an "auditing plan" for critical RA tasks.
    - Managing CAPAs/Auditing Findings and Post-Approval Commitments.
    - Supporting QMS audits and integration tasks.
    - Reviewing Management Review Metrics results.

    About Us:
    Intellectt Inc is a leading company focusing on providing high-quality services in various industries.

    Join us in this exciting opportunity to contribute to our Regulatory Affairs team!
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