A global company is looking to add a Regulatory Affairs Manager to their team to help support their growth. The Regulatory Affairs Manager will report to the Director of Regulatory Affairs and will help support a new platform of products. This is a Direct-Hire and permanent position located in Lake County, IL. This person will not have direct reports, but will have some responsibility mentoring and helping junior members of the team.
This Regulatory Affairs Manager will be responsible for global submissions for a combination device product line. This person must have a strong technical background with Medical Devices and some pharmaceutical experience.
The Regulatory Affairs team is responsible for the Full Life-Cycle Management of the combination devices, and this person must have strong product development experience. The company is working on cutting edge products and this person will help develop a successful Regulatory Strategy to bring them to market.
Here are some of the Requirements/Expectations:
- 4 Year Degree, Life Sciences Preferred
- Master's or Ph.D. Favored
- 5+ Years of Regulatory Experience with Medical Devices
- Author of Multiple 510(k)'s and Global Submissions
- Excellent Medical Writing Skills - Capable of telling the RA Story
- Pharmaceutical Regulatory Experience is a plus
- Able to work independently and communicate cross-functionally
- Must have strong development/design control experience
- Proven history of anticipating issues/problems and preventing them
If you would like to learn more about this position please submit your resume to Brandon Johnson at Real Staffing. Interviews will begin next month.
Sthree US is acting as an Employment Agency in relation to this vacancy.