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Alberto Gutiérrez

Alberto Gutiérrez

Chemistry

Bethesda, Maryland
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Expert Details

Dr. Alberto Gutiérrez, Ph.D. is an accomplished expert in chemistry with extensive experience in regulatory affairs and scientific leadership. He earned his BA in Chemistry from Haverford College in 1980, followed by an M.A. and Ph.D. in Chemistry from Princeton University. His postdoctoral work includes fellowships at the Universität Bern, Switzerland, and the Massachusetts Institute of Technology.

Dr. Gutiérrez has a distinguished career at the FDA, where he held several leadership roles within the Center for Devices and Radiological Health (CDRH), including Director of the Office of In Vitro Diagnostics and Radiological Health (OIR) from 2011 to 2017, and Acting Director of the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) from 2009 to 2011. He also served as Deputy Director for New Product Evaluation at OIVD and held various positions in the Division of Chemistry and Toxicology Devices.In addition to his work with the FDA, Dr. Gutiérrez has been a Partner and Expert Consultant at NDA Partners LLC since 2017. His expertise spans the fields of chemistry, toxicology, and medical device evaluation, contributing to both regulatory guidance and product development.

A previous Expert Challenge Study on Alberto Gutiérrez revealed:

Total Challenges1
Direct Challenges1
Indirect Challenges 0
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