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

    INTELLECTT INC
    INTELLECTT INC Santa Clara, United States

    3 weeks ago

    Intellectt Inc background
    Description
    Hello,

    I Hope you are doing great.

    This is Bhanu from Intellectt INC; weve got an important role Regulatory Affairs Compliance Specialist - Santa Clara, CA with one of our prestigious clients. Interested candidates can please send your updated resume at

    Role: Regulatory Affairs Compliance Specialist

    Location: Santa Clara, California

    Duration: 6 Months

    Job Description

    This role will provide compliance support to the Regulatory Affairs organization by
    • Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics.
    • Managing strategic program for RA audit preparedness including anticipatory identification of risks, mitigation of risks identified during the audit process, and preventive actions for risks.
    • Supporting quality system integration for acquisitions and new product introductions.
    • Identifying and implementing system and/or systemic processes.
    • Supporting tracking and maintenance of regulatory post-approval commitments.
    • Driving quality system process improvement initiatives

    Initiatives Include But Are Not Limited To

    • Establishing audit support for integration products,
    • Improving and Maintaining the quality system procedures (e.g., change management)
    • Liaising with cross-functional partners and international affiliates to meet audit compliance needs and driving to implementation/resolution.
    • Participating in audit backrooms, and
    • Participating in RA projects.

    Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations. Exposure to Medical Device US and CE regulations, Quality Systems, a Quality role, or a Compliance role is a plus.

    List Of Tasks

    • RA Change Requests Tracking and Closure
    • Change management
    • Develop and implement an auditing plan for critical RA tasks (e.g., mock audits for Technical Files/Technical Documentations, Impact Assessments, Archival) as part of audit risk mitigation activities.
    • CAPAs/Auding Finding management.
    • Post-Approval Commitments management
    • Support QMS audits from an RA perspective
    • Support QMS Integration tasks
    • Management Review Metrics results

    Thanks & Regards,

    Ajay Bhanu

    Intellectt Inc

    Direct:

    Desk number : Ext: 159

    517 Route 1 South, Suite 1115 Iselin, NJ 08830

    WhatsApp:
    #J-18808-Ljbffr
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