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Learning Level: Foundational
Learning Level: Foundational
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Learning Level: Expert
Networking Event
Networking Event
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Sponsor Presentation
Ticketed Event
Ticketed Event

Maham Ansari, MS, RAC

Senior Director, Regulatory Affairs
Precision for Medicine
Frederick, Maryland, United States

Maham Ansari is a Senior Director of IVD Regulatory Affairs at Precision for Medicine. In her current role, her focus is on companion diagnostic co-development programs, where she leverages her regulatory expertise to secure approvals in the US, Europe and beyond for companion diagnostics with a specific focus on gene therapy. Maham has extensive global regulatory leadership experience in the medical device and in vitro diagnostics industry. From major multinationals to small start-ups, Maham’s expertise includes full life cycle management of highly complex medical devices and IVDs from all stages of product development, execution of global regulatory strategies and leading post-market surveillance activities. She is well versed in leading interactions with Regulatory Authorities as well as managing complex submissions with a proven track record of successful approvals. Maham received an Undergraduate degree in Chemical Engineering from the University of Toronto and a Master’s in Bioscience Regulatory Affairs from the Johns Hopkins University. She also maintains a Regulatory Affairs Certification through RAPS and serves on the Advisory Committee Board at the Northeastern University post-graduate programs in Biotechnology and Regulatory Affairs.

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