We are currently recruiting for a Regulatory Affairs Manager to join our New Product Development team. The Regulatory Affairs Manager will report to the Director of Regulatory Affairs and have no direct reports under them.
The team is working on a new line of electromechanical Class II Medical Devices and PMA's. These devices are complex and cutting edge technology. The Regulatory Affairs Manager will provide the Regulatory Strategy and work Cross-Functionally to achieve the Company's business goals. This person will prepare submissions and directly interface with Regulatory Agencies.
The Salary Range for this Position is $95,000 - $145,000 Plus a Bonus
Please read the following Requirements:
- 4 Year Bachelor's Degree: Engineering or Life Sciences Preferred
- RAC or RAPS Certified is a plus
- 5 years of Class II Medical Device Experience
- Experience with Cardiology/Hardware/Software Devices
- Ability to Author 510(k) Submissions
- Directly Communicated with FDA
- Ability to Provide Regulatory Strategy for Cross-Functional Groups
If you are interested in this opportunity please contact Brandon Johnson at Real Staffing
Sthree US is acting as an Employment Agency in relation to this vacancy.