Sr. Regulatory Affairs Specialist
Medical Device company is seeking a Regulatory Affairs Specialist to join their team!
- Prepare FDA submissions (i.e. 510(k), Pre-Sub, IDE, PMA) including writing the text, analyzing relevant documents (e.g. test reports, protocols, labeling, design requirements, manuals), and preparing documentation that will accompany the submission
- Support international and domestic filings/registrations, including updating technical files and design dossiers;
- Provide proactive knowledge and expertise as a representative of Regulatory Affairs on project teams;
- Demonstrate technical and product-related industry knowledge and understanding of a product’s distinguishing features in the market;
- Analyze advertising, labeling and public communications for regulatory compliance;
- Ensure compliance with design control regulations during product development and delivery activities;
- Report any significant regulatory issues related to a product’s release;
- May represent RA department in project meetings and provide regulatory guidance;
- Support Quality teams with special projects.
- BS in Sciences or Engineering
- 510(k) Submission, Design Dossiers, and Technical Files.
- 5+ years of experience