RefleXion Medical

Compliance

• Contribute to the preparation and support of regulatory submissions and filings for U.S. FDA and other global regulatory bodies (e.g., Notified Bodies for CE marking, Health Canada).
• Assess and document product changes for regulatory impact.
• Collect and organize information related to product changes and their impact on global regulatory approvals.
• Support product development teams in implementing international regulatory requirements.
• Assist with maintaining annual licenses, registrations, and regulatory listings to ensure continued compliance.
• Support adverse event reporting to regulatory agencies and internal stakeholders.
• Monitor changes in regulations and standards and communicate impacts to internal teams.
• Maintain and update regulatory affairs procedures using established change control processes.
• Maintain and track applicable external regulatory standards.
• Support continuous improvement of regulatory submission processes.
• Perform other related duties as assigned.

Regulatory Affairs Specialist – 6 Month Contract