We are partnering with a rapidly growing Medical Device and Diagnostic company with finding a Senior Regulatory Affairs Specialist to join their team. The company is a medium size and is experiencing consistent growth. This is a direct-hire permanent position and located in the Northern Suburbs of Chicago.
The Senior Regulatory Affairs Specialist will be responsible for the full Life-Cycle Management of Medical Devices and Diagnostics. This person will sit on cross-functional core teams for new product development and support the emerging markets. The Senior Regulatory Affairs Specialist will also be responsible for Global Regulatory Submissions.
The Salary for this Position is up to $95,000 + Bonus
Please Read the Following Requirements/Expectations:
- 4 Year Bachelor's Degree, Life Sciences Preferred
- Higher Education a Plus
- RAC Certifications a Plus
- 3+ Years of Regulatory Experience with Medical Devices
- Author of Multiple 510(k)'s, Tech Files, and Global Registrations
- Experience with CE Mark
- Directly communicated with Regulatory Agencies
- IVD Experience is a plus
- Experience with a Global Regulatory Strategy for Emerging Markets
If you are interested please submit your updated resume with availability for a phone screen.
Sthree US is acting as an Employment Agency in relation to this vacancy.