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Director, Quality Assurance & Regulatory Affa
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Full-time
- Plan and direct the organization’s Quality Systems and Regulatory policies, objectives, and initiatives.
- Serve as the Company’s Management Representative and Person Responsible for Regulatory Compliance (PRRC), and be the lead contact for all regulatory agencies, notified bodies, and international representatives, including but not limited to MDSAP and EU-MDD/MDR countries.
- Communicate changes to the Quality System and/or to product requirements, defined in the Design History File, Design Dossier, and/or Technical Files to the applicable Notified Body. Direct and prepare regulatory documentation for submission to regulatory agencies inside and outside the United States, specifically key International markets including but not limited to Canada, the EU, Asia Pacific, the Middle East, Latin America and Australia to achieve product registrations.
- Preserve the rights of the Corporation when acting as liaison between the Corporation and the FDA.Maintain verified accredited wholesale drug distribution certification (VAWD) in all 50 states within the U.S.Ensure that the Company’s portfolio of Medical Devices, Drugs, and Cosmetics are compliant with all applicable laws for manufacturing, marketing, sales and or distribution in the relevant global markets.
- Create and present employee evaluations, subject to the approval of the COO.Assesses subordinate employee training needs and conduct or recommend training as necessary.
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