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Jesse C.
Founder @Riskbased.Ai
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WORK HISTORY
Founder @Riskbased.Ai
AI Surveillance for FDA data @ fdarisk.com
EDUCATION
UC Irvine
Bachelor of Science - BS
The Johns Hopkins University
Master of Science - MS
ABOUT JESSE C.
I build quality systems for hardware that goes inside people.At Neuralink, I stood up the GMP/GCP programs from scratch and led the quality workstream that got a Class brain implant through FDA first-in-human clearance. That milestone correlated with a $7B valuation jump.Before that, I secured FDA Approval and regulatory controls at JUUL Labs.On the side, I built Riskbased.ai: cloud dashboards for FDA recall analytics and post-market risk intelligence.What I do well: stand up quality systems from zero, pass federal audits, write FDA submissions, and ship regulated products. I think AI will fundamentally reshape how we do compliance—I\'m building toward that.ASQ certified (CQE, CQMOE, Six Sigma, Pharma GMP). Top 100 MedTech risk voice (MLV 2025). English, Mandarin, Spanish.
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