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ai governance iso 13485 fda samd iso 14971📋 Description
- Lead regulatory filings with FDA, NYS, CMS, CAP.
- Interpret evolving U.S. regs for IVDs, SaMD, telehealth.
- Advise leadership on regulatory strategy for home diagnostics and software.
- Develop regulatory strategy for AI/ML diagnostics and CDS tools.
- Liaise with regulators; support audits and responses.
- Partner with Product/Tech/Legal to embed regulatory by design.
🎯 Requirements
- Bachelor's degree in Life Sciences or Regulatory Affairs; advanced degree a plus
- 7–10 years in regulatory affairs/quality for diagnostics, devices, or digital health
- Expertise in 21 CFR Part 820, ISO 13485, 14971, 62304
- Expertise in FDA submissions (510(k), Convenience Kit, EUA)
- Expertise in CLIA and NYS accreditation requirements
- Hands-on experience with software-driven healthcare products (SaMD/CDS)
🎁 Benefits
- Annual bonus eligibility
- Health, dental, vision, and mental health insurance
- 401(k) with company match
- Flexible PTO
- Monthly $100 wellness stipend
- Various other perks
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