Recruiting for a Global Medical Device company in the greater Minneapolis area, who is seeking a Regulatory Affairs Manager. You will be working on electro-mechanical medical devices. These are exciting products, it involves working on advanced catheter systems, guidewires, medical balloons, extrusions, and laser micro-machines and welded assemblies and are a single source of manufacturing expertise for advanced medical devices.
- Manage a team of regulatory affairs Specialists
- 510K Authorship and management of submission process
- Work closely with the R&D development team to provide regulatory input and guidance.
- Responsible for development of labelling.
- Management of MDSAP audit
- Bachelor's degree
- 8 years of Regulatory Affairs experience in the medical device industry
- Strong leadership skills, and ability to work effectively within a team
- Previously authored 510K
Salary is depending on experience, range up to $130K & 6% BONUS
Please apply or call Francesca White if you are interested, and Real Staffing with reach out to discuss this opportunity. 312-453-9077
Sthree US is acting as an Employment Agency in relation to this vacancy.
Regulatory Legislation And Guidelines