Regulatory AI/ML SaMD Engineering Lead

Neko Health is seeking an experienced 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 actionable steps, embedding regulatory thinking into software development and sprint cadences.

You will lead submissions, audits, and ongoing post-market surveillance, ensuring compliant, safe software products and effective collaboration across functions.

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