Tricia Cregger in

Tricia Cregger

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Director of Quality / Regulatory at COLTENE USA
📍 Akron, Ohio, United States

Tricia Cregger is a strategic global regulatory and quality leader with deep expertise in Class II medical devices. Holding a Ph. D. from The University of Akron and a RAC (Global) certification, she has extensive experience in 510(k) submissions, quality systems, and design controls, having held senior roles at COLTENE USA and STERIS Corporation.

Originally a scientist with a background in polymer science and physics, Tricia has transitioned her analytical skills into the regulatory field. Based in the Akron, Ohio area, she has shown an interest in finding innovative and efficient approaches to complex regulatory challenges, including advocating for the use of AI in her field.

She holds multiple patents, including one for a genetically engineered biological indicator used for monitoring sterilization processes.

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Experience
18 Years
Current Role
Director of Quality / Regulatory
Job Level
Mid-senior
Location
Akron, Ohio, United States
Personality Overview

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Decision Approach
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Priorities

Topics Tricia cares about

Medical Device Regulation
Her career is focused on regulatory affairs for Class II medical devices, including 510(k) submissions, de novo applications, and Quality Systems Regulations.
Regulatory Innovation
She identifies as an "AI Advocate" and posts about creating clear, repeatable, and innovative frameworks to improve the efficiency and clarity of regulatory submissions.
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Career

Work history

4-2025
Director of Quality / Regulatory
COLTENE USA
6-2019 - 4-2025
Director of Regulatory / Research and Development
COLTENE USA
10-2017
Regulatory Affairs Manager
Coltene Whaledent, Inc.
1-2017 - 10-2017
Senior Manager, Regulatory Affairs
STERIS Corporation
12-2013 - 12-2016
Regulatory Affairs Manager
STERIS Corporation
In the press

Media appearances

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Education
1997 - 2002
Doctor of Philosophy (Ph.D.)
The University of Akron
1995 - 1997
Master of Science (M.S.)
The University of Akron
Social presence
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Behavioral profile

DISC profile (public)

DISC behavioral profile

Dominance, influence, steadiness, and calculativeness scores with guidance on how this person prefers to communicate and decide.

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