Permanent position: Regulatory Affairs Specialist needed for an amazing opportunity in the Billerica, MA area. The Regulatory Affairs Specialist is responsible for providing support for new product development teams and transforming the on-market product documentation in alignment with regulatory requirements. Apply now for immediate consideration!
Responsibilities for the Regulatory Affairs
Requirements for the Regulatory Affairs
- Focus on improvement of the technical files and risk management documentation including reviewing product/manufacturing process changes, supplier changes, new and revised engineering protocols and reports, and reviewing product labeling.
- Ensure compliance with the design control process and with the Quality Management System to manager's specifications and regulations.
- Working closely with the R+D, Engineering and QA/RA groups to ensure product development follows industry standard rules and regulations.
- 3-5 years experience in a related industry (ideally medical device).
- BS or BE in a relevant science or engineering discipline.
- Must understand domestic FDA and foreign regulatory requirements for the manufacture of medical devices.
- Must understand design control and technical file compilation as well.
- Must be able to meet deadlines, prioritize work, take the initiative to follow-up on outstanding issues, complete assigned tasks, handle multiple tasks, and work independently.
- Industry leading benefits package available! Apply now!