Related skills
digital health fda 510(k) samd de novo📋 Description
- Develop regulatory strategies for SaMD, AI/ML, wearables, and digital health.
- Advise cross-functional teams on regulatory strategy across concept, design, modeling, and validation.
- Collaborate with product/engineering/AI teams to assess regulatory implications of features and claims; recommend strategies.
- Develop regulatory approaches for emerging tech (foundation models, generative AI, adaptive algorithms).
- Act as SME on FDA digital health, SaMD, AI/ML regs, international regulations, and trends.
- Lead FDA and EU submissions (Q-Sub, 510(k), De Novo, EU MDR docs).
🎯 Requirements
- Bachelor's degree in Regulatory Affairs, Engineering, or CS; advanced degree preferred
- 8+ years regulatory affairs in medical devices
- Experience developing SaMD/digital health/AI-enabled regulatory strategies
- Strong understanding of FDA regulations; Q-Sub, 510(k), De Novo experience
- International medical device regulations knowledge; FDA and EU MDR
- Familiarity with AI/ML, foundation models, generative AI in healthcare
- Experience partnering with software engineering, product, data science teams
- Strong written and verbal communication skills; ability to translate requirements
🎁 Benefits
- Role based in the Boston, MA office; relocation may be required
- Equal Opportunity Employer; participates in E-verify
- Equity and comprehensive benefits included
- Diversity and inclusion-focused workplace
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