Job Summary
A medical technology company has a current position open for a Remote Senior Staff Regulatory Affairs Specialist.
Candidates will be responsible for the following:
- Developing and executing global regulatory strategy for new and/or modified medical devices
- Preparing complex regulatory submissions and/or presentations
- Serving as a regulatory affairs representative to improve awareness, visibility and communication on regulatory requirements
Qualifications for this position include:
- Travel: Up to 25%
- A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required
- A minimum of 7 years of experience in an FDA regulated industry
- A minimum of 3 years of Medical Device Regulatory Affairs experience
- General understanding of product development process and design control
