Summary: Primary responsibilities include the development of submissions for domestic US clearances. Additionally, the Sr. Regulatory Affairs Specialist will work with various project teams and provide regulatory support to assigned teams as needed:
Essential duties and responsibilities include the following. Other duties may be assigned.
- Responsible for management of preparation and maintenance of U.S. regulatory submissions and other premarket filings and registrations to acquire appropriate commercial distribution clearances in an expeditious manner.
- Determine/document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with Regulatory management as needed.
- Control and maintain regulatory records.
- Represent Regulatory Affairs on various design and development teams by attending team meetings and providing the required plans, procedures and regulatory decisions. Confer with other departments about the regulatory requirements of new product designs and/or changes to existing designs.
- Review and approve new documents and product changes for compliance, and to determine if a new premarket application is required.
- Responsible for assisting Engineering in maintenance of Design History Files and related records on an as needed basis, and where regulatory responsibilities permit
- Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry.
- Strong knowledge of US FDA Quality System Requirements (QSR), and ISO 13485, various international regulations.
- Experience authoring medical device 510(k) pre-market notifications
- Experience with orthopedic implant product design and project development process
- Experience in medical device or pharmaceutical industry
- Bachelor's degree from four‑year college or university
- Five (5) years related experience with regulatory submissions