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    • Sr. Regulatory Affairs Specialist - Irvine, CA - PRISMATIK DENTALCRAFT, INC.

    PRISMATIK DENTALCRAFT, INC.
    PRISMATIK DENTALCRAFT, INC. Irvine, CA

    1 week ago

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    Description

    Regulatory Affairs Specialist

    At Prismatik Dentalcraft Inc., we are seeking a skilled Regulatory Affairs Specialist to join our team.

    • Prepare and submit product registrations and submissions to FDA and other regulatory bodies, ensuring compliance with applicable regulations and guidelines.
    • Maintain company registrations and device listings in the US, Canada, and the EU, staying up-to-date on current regulations and changes.
    • Analyze and report department metrics, identifying areas for improvement and implementing process enhancements.
    • SUPPORT AND MAINTAIN TECHNICAL FILES, MDD CERTIFICATIONS, AND DECLARATIONS OF CONFORMITY IN SUPPORT OF EU PRODUCT REGISTRATIONS/CE MARK.
    • Inform coordinator of product recalls, ensuring prompt action is taken to address any issues.
    • Perform and support internal, external, and third-party audits, fostering a culture of compliance and quality within the organization.
    • Maintain knowledge on current regulations and guidelines, providing expertise to colleagues and management as needed.
    • Evaluate compliance with applicable regulations, project policies, and procedures, identifying areas for improvement and implementing corrective actions.
    • Review and write standard operating procedures (SOPs) and other RA/QA policies, ensuring clarity and effectiveness.
    • Collaborate with technical staff to foster understanding of SOPs and guidance documentation, promoting a culture of compliance and quality within the organization.
    • Compose audit plans and reports, documenting findings and recommendations for improvement.
    • Conduct audits and inspections of GMP and non-regulated documentation, ensuring compliance with regulatory requirements.
    • Track internal and external corrective and preventive actions, ensuring timely resolution of issues.

    Requirements

    • Bachelor's degree in a related field preferred
    • Minimum five (5) years of experience in Regulatory Affairs
    • Experience in preparing (writing) domestic and international product submissions, required

    About Us

    Prismatik Dentalcraft Inc. is a division of Glidewell Dental, a leading provider of dental solutions. We are committed to delivering high-quality products and services that meet the evolving needs of the dental industry.

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