Medical Device Regulatory Affairs Specialist

Job Summary

Collaborating with product engineering teams, the remote Principal/Lead/Senior Medical Device Regulatory Affairs Specialist will develop regulatory strategies, manage pre-market submissions, and ensure compliance throughout the product lifecycle for AI-enabled, cloud-native software applications in the healthcare sector.

Key responsibilities

• Assess product functionality and develop regulatory strategies in collaboration with engineering teams
• Create and manage pre-market submissions and maintain documentation for ongoing market authorization
• Support audits and manage compliance-related projects for health-related products

Required qualifications

• 10+ years of experience in regulatory affairs within the medical device industry
• Experience with submissions such as 510(k) and EU Technical Files
• Familiarity with quality management systems, preferably ISO 13485 and ISO 14971
• Advanced degree preferred in a relevant field
• Experience interacting with regulatory bodies and understanding of risk management