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

    Intellectt Inc background
    Description
    Hello,

    I Hope you are doing great.

    This is

    Bhanu

    from Intellectt INC; we've 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