MEIRxRS Tulsa, OK, United States
Aug 30, 2017Full time
Relocation assistance to Tulsa, OK approved for this position. Required Minimum of 5 years’ experience in a Quality Systems / Regulatory Compliance environment 3-5 years’ experience in medical device industry preferably in Dental Equipment/Instrumentation 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, etc.) Solid experience in Medical Device Risk Management (ISO 14971) Knowledge of international standards requirements according to IEC 60601, 62304, 62366, ISO 14457 Experience in supporting preparation of Regulatory submissions, both domestic and international The Qualified Candidate will be 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 R&D, 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.