Unknown Company

AI/ML SaMD Regulatory Engineering Lead

remote, oh • Posted 1 weeks ago
Onsite Full Time Management & Operations

Neko Health seeks an RA Engineering Lead for AI/ML SaMD to shape regulatory strategy across EU MDR, FDA, and UK MDR. You will work with engineering, quality, and clinical teams to translate complex requirements into clear actions and ensure compliance is embedded in sprint cadences.

You will guide submissions, audits, and post‑market activities while mentoring a small regulatory team and advancing medical software governance across the organization.

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