Medical Device Regulatory Affairs Specialist

Job Summary

Collaborating with product engineering teams, the full-time Medical Device Regulatory Affairs Specialist will develop regulatory strategies and manage pre-market submissions for AI-enabled, cloud-native software applications in a remote setting.

Key responsibilities

• Assess product functionality and regulatory strategy in partnership with engineering teams
• Manage pre-market submissions and ensure compliance with global regulatory authorities
• Maintain documentation and conduct post-market surveillance to uphold market authorization

Required qualifications

• 10+ years of experience in Regulatory Affairs within the medical device industry
• Experience authoring submissions such as 510(k) and EU Technical Files
• Familiarity with ISO 13485, ISO 14971, and 21 CFR parts 1000/1001
• Advanced degree in a relevant field preferred
• Experience with software as a medical device (SaMD) is ideal