Regulatory Affairs Specialist

Position is responsible for ensuring that regulatory submissions are appropriately developed for approval and clearance of orthopedic products and their respective accessories. These Regulatory submissions can include, but are not limited to class III design dossiers, preparation of technical files for class I, IIa, IIb (EU). Ensures regulatory interface throughout the product realization process and during the entire product life cycle including post-market surveillance.

Principal Duties and Responsibilities

1. Sit on design review teams and provide interactive feedback and assist in the development of supporting documentation.
2. Develop Regulatory strategy for projects.
3. Assist in the development and implementation of post-market surveillance.
4. Develop documents to submit to Notified Bodies and FDA
   • Design Dossiers, Technical Documentation and Technical files (as per MDD 93/42/EEC or MDR (EU) 2017/745)
   • Change notifications.
   • Premarket notifications (510(k))
   • Premarket Applications (PMA) – original or supplements or annual report
   • Investigational Device Exemption (IDE)
5. Develop internal documentation when formal FDA submissions are not required (LTF or Memo-to-File).
6. Supports, approves, and participates (as necessary) in the development of package inserts, evaluation of promotion and advertising material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status
7. Review and approve all Engineering Change Requests (ECRs).
8. Assist in the development and updating of internal operating procedures.
9. Submit documents to support International registration submission requests
10. Develop progress reports and other misc. reports as needed.
11. Participate in other RA activities as needed.

Expected Areas of Competence

• Good knowledge of US and EU medical device regulations.
• Basic Knowledge of international medical device regulations.
• Strong attention to detail.
• Strong computer skills, including word processing, spreadsheet and data programs.
• Good oral and written communication skills.

Education/Experience Requirements

• Knowledge and skills identified are typically acquired by completing Bachelor’s or higher degree in clinical/science field, or similar work experience. 
• Typically, one to three years’ experience in medical device or pharmaceutical regulatory affairs is desired.

Travel Requirements

Limited travel required (up 5%)