Relocation assistance to Tulsa, OK approved for this position.
Key requirements for candidates:
- Experience in New Product Development quality aspects for medical devices
- Able to deal at high level across technologies that might be out of his core competencies
- Awareness of international medical standards and regulations
- Risk management for medical device (14971)
- Ability to work in great autonomy since remote from the rest of the team
- Engaging and communicating effectively.
- 5+ years’ experience in a Quality Systems / Regulatory Compliance environment
- 3+ 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
- Experience in supporting preparation of Regulatory submissions
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.