Product Development Compliance Manager – Medical Device Tulsa OK
Product Development Compliance Manager – Tulsa OK
Relocation assistance to Tulsa, OK approved for this position.
- Minimum of 5 years’ experience in a Quality Systems / Regulatory Compliance environment
- 3-5 years’ experience in medical device industry preferably in Endodontics Irrigation and Obturation
- BS in Bio Sciences, Engineering or related field
- Solid understanding of medical device design control and regulations as well as quality management standards (ISO 13485, 21 CFR part 820, EU Medical regulations, Canadian Medical Device regulation, MHLW M.O. 169 )
- Solid experience in Risk Management (ISO 14971)
- Knowledge of international standards requirements according to IEC 60601, 62304, 62366, ISO 14457
- Experience in supporting preparation of 510k/PMA submissions, EU Technical File compilation and other ROW product registration
- Quality agreement preparation
- Knowledge of dental environment is preferred
Our client is in need of a Product Development Compliance Manager in Tulsa OK. This role is responsible for managing and insuring compliance of product development, product modifications and product sustaining activities with the applicable international regulations and standards. The position will provide quality normative expertise and guidance to RD, Marketing, labeling, clinical and manufacturing for an efficient and successful introduction of products on worldwide markets. In addition, this position will provide support to Regulatory Affairs for product registrations.
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