Steven Niedelman

Steve Niedelman

Lead Quality Systems and Compliance Consultant
King & Spalding LLP
 

 

Steve Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement and policy matters. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure FDA compliance. Mr. Niedelman retired from the FDA in 2006 after a 34-year distinguished career, serving as the deputy associate commissioner for regulatory affairs and as chief operating officer of the Office of Regulatory Affairs. He also assisted in the day-to-day management of the FDA’s nearly 3,400 field staff responsible for investigative and laboratory operations. Mr. Niedelman’s prior FDA service included the roles of director and deputy director of the FDA’s Office of Enforcement, where he was responsible for oversight and consistency of compliance policy, enforcement and recall activities.