Regulatory Affairs, Program Manager

ThinkingAhead

Fantastic opportunity within Regulatory Affairs- Med Device!

Along with joining a fantastic smaller team, who's dedicated to providing the best treatment within wound care, this candidate will: 

- Manage the regulatory aspects of biotechnology-derived products, including the applications submitted to the FDA and other regulatory agencies
-Lead US Regulatory Affairs program for the development of products for submission of 510(k), PMA, and PMA-S
-Provide regulatory leadership and partner with other departments to support multiple platforms and product lines for commercialization and post-marketing activities
-Manage certain aspects of Medical Device Reporting (MDR)
-Be responsible for writing regulatory assessments and strategy decisions in conjunction with corporate change control procedures

...and much more! Room for growth and an opportunity for a true career within this growing organization!

Requirements: 

- Bachelor’s degree in a scientific discipline
- At least 5 years' experience in the medical or life science industry with at least three years of increasingly responsible experience in Regulatory Affairs
- Solid working knowledge of device/biologic development process and of FDA regulatory requirements for biotechnology products in the U.S.
- Must have successfully submitted regulatory filings to the FDA and other regulatory agencies, including 510(k), PMA, PMA-S, and MDR submissions
- Experience working on INDs and BLA submissions preferred