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