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Director of Regulatory Affairs / Quality Assurance
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Full-time
- In conjunction with other internal departments, the QA Director will implement a systematic approach to quality management to ensure adherence to GMP requirements.
- The Senior Director of QA/RA will also be responsible for planning and implementing an effective internal audit program of all company processes and procedures.
- The position calls for the effective management of the RA and QA departments and their members with responsibilities for all quality systems, direct collaboration with the new product development team, overseeing all regulatory affairs including regulatory strategies and guidance based on U.S. and International requirements
- Preparation of responses to Regulatory authorities’ supplements, and amendments; participation in final company document review and corrections; preparation of additional information as needed.
- Experience in USFDA and ISO auditing and the ability to prepare and submit documents to FDA, such as 510(k) Premarket Notifications, Premarket Approval Applications, (PMAs), New Drug Applications (NDA).
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