This is an opportunity to join a global life sciences company in their medical devices division with complex devices and regulatory pathways. Working on predominantly PMA supplements and new 510k submissions, you'll have the chance to develop project management skills within the role.
This is an FTE role that is 80% remote, but requires someone within driving distance of site to be available in person for audits, submissions, and other meetings.
Main Responsibilities
- Coordinate, prepare, and execute regulatory documentation for the FDA including Premarket Notification 510(k), Pre-Sub, IDE, and PMA submissions in a timely manner. Act as liaison with FDA regarding product submissions.
- Represent RA and demonstrate leadership in sophisticated product development teams by identifying and interpreting requirements, and providing meaningful mentorship throughout the product development cycle prior to regulatory submission.
Experience Required
- 7+ years' Regulatory Affairs experience within the Life Sciences industry, with exposure to complex devices (either PMA, De Novo, or BLA submission) required.
- Strong technical writing skills, a writing sample will be required as part of the interview process.
- Bachelor's in an engineering or life sciences discipline.
- Must live within 2 hours driving distance of the site and be OK with going on-site when required.
