FDA Regulatory Consultant AI SaMD in Cardio Care
Listed on 2026-10-09
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Healthcare
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.
We have an opening for a FDA Regulatory Consultant for AI SaMD in Cardio Care in Chicago, IL, United States within Legal, Other.
As a FDA Regulatory Consultant for AI SaMD in Cardio Care, you will play an important part at Regain in Chicago, IL, United States.
We invite applications for the FDA Regulatory Consultant for AI SaMD in Cardio Care position located in Chicago, IL, United States.
The following position is for a FDA Regulatory Consultant for AI SaMD in Cardio Care with Regain.
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