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Learning Level: Advanced
Learning Level: Advanced
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Learning Level: Expert
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Learning Level: Foundational
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Learning Level: Intermediate
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Maham Ansari, MS, RAC

Senior Director, Regulatory Affairs
Precision for Medicine
Frederick, Maryland

Maham Ansari is a Senior Director of IVD Regulatory Affairs at Precision for Medicine. In her current role, she heads up 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 over 18 years of progressive 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.

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