Page 156 - ALMExperts 2024 Mid-Atlantic Directory

MEDICAL RESUMES ALM EXPERTS: Mid-Atlantic Edition 2024

Steve Silverman, Pres.
The Silverman Group
[email protected]; (301) 213-5780

Steve Silverman is the President of The Silverman Group (www.silverman-group.com), a
consultancy that serves medical product companies on regulatory, strategy, and policy issues.
Before this, Steve was a Senior Expert with McKinsey & Co., where he counseled
pharmaceutical, medical device, and other clients on regulatory strategies, product compliance
and quality, and stakeholder communication.
Steve’s professional experience includes nearly two decades in federal service, with extensive
time in FDA leadership roles. At FDA, Steve directed the device center’s Office of Compliance,
where he led device-quality initiatives, engaged Congress and the press, and guided the office’s
reorganization. Steve’s FDA roles include Assistant Director of the drug center’s Office of
Compliance, where he implemented drug regulations, policy, and public communications
about prescription and over the counter drugs. Steve began his FDA work as an Associate Chief
Counsel, where he led enforcement actions against drug and medical device companies.
Steve’s past work includes service as a trial attorney with the US Department of Justice.

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