Senior Director/Director, Regulatory Affairs

A global medical device company is seeking a Director/Senior Director of Regulatory Affairs to join their team. With marketed products and products in earlier stage development, the team would like to bring in an experienced Regulatory Affairs leader with class II and III Medical Device experience.

Responsibilities include:

- Developing and maintaining connection with United States FDA
- Develop, coordinate, and implement regulatory strategies to ensure product approvals/clearances/registrations (PMA and 510k)
- Participate and/or lead global teams as regulatory representative
- Prepare and/or review complex regulatory documents to ensure timely product approvals
- Review promotional, advertising and labeling to ensure accuracy and compliance with regulatory agencies

Qualifications:

- Strong expertise in U.S. Regulatory submissions/strategies (PMA/510k)
- Strong ability to negotiate
- Ability to mentor and/or manage employees
- 10+ years regulatory affairs experience (medical device)
- B.S. (scientific field a plus)

To find out more about Real please visit www.realstaffing.com