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    Sr. RA Specialist - Irvine, United States - The Execu|Search Group

    The Execu|Search Group
    The Execu|Search Group Irvine, United States

    1 week ago

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    Description

    A recognized services company in California is currently seeking an experienced Regulatory Affairs Specialist to join their staff in the Greater Los Angeles area in a Senior-level position.

    Responsibilities:

    The Senior Regulatory Affairs Specialist will:

    • Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies
    • Maintain company registrations and device listings in the US, Canada, and the EU
    • Analyze and reports department metrics
    • Perform and support internal, external, and third-party audits.
    • Evaluate compliance with applicable regulations, project policies, and procedures
    • Review and write standard operating procedures (SOPs) and other RA/QA policies, as necessary
    • Compose audit plans and reports
    • Conduct audits and inspections of GMP and non-regulated documentation
    • Track internal and external corrective and preventive actions
    • Perform other duties, as needed
    Qualifications:
    • 5+ years of experience in Regulatory Affairs
    • Knowledge and understanding of related State and Federal regulations and procedures
    • Knowledge of FDA 510K and ISO 13485 Standards
    • Knowledge of Regulatory Affairs regulations, guidance, and procedures
    • Microsoft Office proficient
    • Solid analytical, quantitative and problem solving skills
    • Great interpersonal skills
    • Excellent communication skills (written and verbal)
    • Strong attention to detail
    • Highly organized
    Desired Skills:
    • Bachelor's Degree
    • Certification in Regulatory Affairs and Auditing
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