- Wilmington, Massachusetts, United States
- On-site
- Full-time · Principal
- 8+ years
The Principal Regulatory Affairs Specialist serves as the highest-level individual contributor within Regulatory Affairs and is responsible for developing and executing global regulatory strategies that support product development, registration, commercialization, market expansion, and lifecycle management of Elevaris products.
Responsibilities
- Develop and lead regulatory strategies supporting new product development, product modifications, market expansion, and lifecycle management
- Serve as the primary regulatory affairs representative on cross-functional product development teams
- Provide regulatory guidance and risk assessments related to design, manufacturing, supplier, and labeling changes
- Lead preparation and submission of 510(k)s, PMAs, IDEs, international registrations, renewals, and regulatory assessments
- Coordinate responses to regulatory agency requests and represent regulatory perspectives with FDA, Notified Bodies, and global authorities
Requirements
- Bachelor’s degree in a scientific discipline
- Nice to have: advanced degree
- Nice to have: RAC certification