Jesse Chen

About Jesse Chen

Pushing the Envelope, with a Culture of Quality & Regulatory Six Sigma |With a rich 12-year background in Manufacturing Operations and Quality Programs, I specialize in steering Regulatory Compliance, Risk Controls, and GxP. I hold numerous ASQ Certifications and a M.S Regulatory Science from JHU. I believe FDA regulatory frameworks can be bolstered with data-driven tools & innovative approaches. Experience Covers: Medical Devices, Brain-computer interface (BCI) Neurotech products, Active Pharmaceutical Ingredients (API), Contract Manufacturing, Supplier Controls, Dietary Supplements, etc.

Regulatory Six Sigma: operational excellence for FDA compliance and burdensome regulatory requirements. Favorite Metric = Right First Time (RFT).Expertise = Leadership, GMP, CAPA, Risk Management, Quality Systems, Regulatory Affairs, HHE, Recalls, FMEA, HACCP, ISO 13485, ISO 14971, Six Sigma, Change Control, Supplier Quality, Contract Manufacturing, Supply Chain, Design Controls.Regulatory Landscape: Proficient across FDA, USDA, FTC, EPA, CPSC. 21 CFR 820, 812, 211, 210, 803, 111, 117, ISO 13485, ISO 14971, ISO 9001, etc.