Deborah Sheffield

Deborah Sheffield has over 25 years of experience in regulatory and quality affairs, with a focus on the medical and biotechnology industries. Deborah'smost recent roles include Senior Vice President of Regulatory and Quality Affairs at Galvanize Therapeutics, Inc. and Galaxy Medical. Prior to that, they held various positions at Galvanize Therapeutics, Inc. (formerly Gala Therapeutics, Inc.), including Vice President and Regulatory Affairs Consultant.

In addition, Deborah has experience as the Owner and Expert Consultant at Sheffield Biomedical Consulting, where they provided their expertise to various clients. Deborah also worked as the Head of Quality Systems, Clinical, and Regulatory Affairs (Contract) at Nativis Inc., Vice President of Clinical, Regulatory, and Quality (Contract) at Kona Medical USA, and Vice President of Regulatory and Clinical Affairs at Northstar Neuroscience, Inc.

Deborah'searlier career includes positions such as Director of Regulatory and Quality at Therus Corporation, Director of Clinical, Regulatory, and Quality at CoAptus Medical Corporation, and Director of Quality Systems at Johnson & Johnson.

Throughout their career, Deborah Sheffield has demonstrated their ability to lead and manage regulatory and quality affairs, as well as provide expert consulting services.

Deborah Sheffield has a diverse education history. Deborah began their academic journey at Kettering University, where they studied Industrial Manufacturing Engineering from 1981 to 1986, ultimately earning a Bachelor of Science in Industrial Manufacturing Engineering (BSIE).

After completing their undergraduate degree, Sheffield pursued further studies in the field of engineering. From 1986 to 1987, they attended Rutgers University, focusing on Manufacturing Engineering at the graduate level.

Following their brief stint at Rutgers, Sheffield shifted their focus to statistics. Deborah attended Oakland University from 1987 to 1988 and obtained a Master of Science (MS) degree in Statistics.

Later on, Sheffield decided to explore the field of Clinical Research. Deborah enrolled at the University of Cincinnati College of Nursing from 1999 to 2001, where they earned a degree in Clinical Research (CRA).

Throughout their education and professional career, Sheffield has also obtained several certifications. In 1991, they became a Certified Quality Engineer (CQE) from ASQ - World Headquarters. In 2001, they obtained the Certified Clinical Research Professional (CCRP) certification from the same institution where they earned their degree in Clinical Research. Most recently, in 2019, Sheffield received Medical Device Regulation Certification from GMED North America.