AFDO RAPS Healthcare Products Collaborative
BIO
Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding

Steve

Niedelman

Lead Quality System & Compliance Consultant

King & Spalding

Steve Niedelman advises on FDA regulatory and enforcement matters, following 34 years at FDA where he served as Deputy Associate Commissioner for Regulatory Affairs and COO of Office of Regulatory Affairs. He previously held positions as executive VP at Quintiles Consulting and senior consultant at Crowell & Moring LLP. At FDA, he oversaw regulatory operations and served on key industry committees.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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