We are currently looking to hire a Senior Regulatory Affairs Specialist. The Company is a medium sized Medical Device/IVD Company that is growing at a great rate. The Regulatory Affairs Specialist will report to the Director of Regulatory affairs and will support the cross-functional groups. This is a direct-hire permanent position and can be fully remote with some travel.
The main responsibilities of the Regulatory Affairs Specialist will be to support the complete life-cycle of our products. We are looking for someone to wear a lot of hats and influence multiple business units. In addition to sustaining activities, this person will work on new product development activities for global submissions such as 510(k) and de novo projects. They will also gain experience in labeling, IVDR, Ad/Prom and other aspects of the life cycle for our products.
The Salary for this position is up to $110,000 plus a bonus
Please review the following requirements:
- 4 year Bachelor's Degree, Life Sciences Preferred
- RAC/RAPS is a plus
- 3+ Years of Regulatory Experience with Medical Devices
- Experience authoring 510(k)'s and global submissions (CE Mark)
- Experience working with Global Registrations
- Proven success working cross-functionally
- Ability to work through the grey areas of Regulations
- Detail Oriented and excellent communication skills
- Experience in the Diagnostics industry is a plus
If you are interested in this opportunity please submit your resume to Brandon Johnson at Real Staffing with your availability for a phone screen.
Sthree US is acting as an Employment Agency in relation to this vacancy.