Compliance

• Assist in the preparation, formatting, and compilation of regulatory submissions (e.g., FDA 510(k), EU MDR Technical Documentation)
• Support the maintenance of regulatory files, declarations of conformity, and device listings/registrations
• Support responses to regulatory agency requests for additional information
• Support U.S. and EU market approval processes and ensure compliance with regulatory standards
• Support post-market submissions (progress reports, annual reports, etc.)
• Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers
• Collaborate with Quality Assurance to ensure continued compliance with applicable regulatory standards
• Participate in internal audits, management reviews, and external audit preparations as needed

Regulatory Affairs Specialist

Director, Global Regulatory Leader

Director, Global Regulatory Leader

Director, Early Precision Medicine Regulatory Affairs

Senior Manager, IT GxP Compliance

Associate Director, Commercial Regulatory Affairs