FDA Regulatory Consultant for AI SaMD in Cardio Care

Regain is seeking an FDA regulatory consultant for a remote, US-based role to shape regulatory strategy for autonomous AI medical software. The position offers a part-time consultant engagement with the option to convert to 0.3 FTE, aligning with ARPA-H ADVOCATE program milestones and multi-site validation requirements. The role requires leading submissions, defining De Novo pathways, and ensuring QMS alignment.