Cheng Zhang, PhD, MBA, joined Biologics Consulting as a Senior Consultant in January 2020 with both FDA and industry regulatory management experience. He has in-depth knowledge of FDA and EU total product life cycle regulation on medical devices and extensive experience in regulatory submission preparation and review. He is also an expert in setting up and maintaining medical device quality system in compliance with ISO 13485 and 21 CFR 820.
Previously, Dr. Zhang was Director of Regulatory Affairs at Inovio Pharmaceuticals, a company that develops novel biologics (DNA-based vaccines) and devices (drug delivery systems) combination products, as well as companion diagnostics. He was responsible for setting US and international regulatory strategies and compiling global regulatory submissions for company’s device products. He oversaw company-wide device quality system for regulatory compliance. He collaborated with different functional groups in developing device design and manufacturing documents, releasing quality system policies and SOPs, conducting post-market activities, etc. He also coordinated drug team and device team to achieve synchronized combination product development.
Before joining Inovio, Dr. Zhang worked at FDA/CDRH/Office of In Vitro Diagnostics and Radiological Health (OIR). He was a scientific reviewer at Division of Immunology and Hematology and Division of Molecular Genetics and Pathology and then promoted to Branch Chief of the Hematology Branch. As a reviewer, he reviewed a wide variety of IVD devices in hematology, immunology, pathology, genetics and companion diagnostics. As a Branch Chief, he led a team of scientific reviewers, consumer safety officers and medical officers in pre-market and post-market regulatory review, policy-making, research, and public communication programs. He participated in decision-making on hundreds of premarket notifications (510(k)), premarket approval applications (PMA), De Novo petitions, CLIA waiver applications, investigational device exemptions (IDE), Pre-submissions, device classifications, recalls classifications, etc.
As a Senior Consultant at Biologics Consulting, Dr. Zhang utilizes his regulatory expertise, communication skills, project management experience, and professional network to help medical device companies design and manufacture safe and effective products and navigate through FDA regulatory processes.
MBA, 2015, University of Massachusetts
PhD, Wood Science/Organic Chemistry, 2005, Oregon State University
ME, Biochemical Engineering, 2000, Zhejiang University, China
BE, Chemical Engineering, 1997, Zhejiang University, China