NORTON, MA, February 16, 2026 /24-7PressRelease/ -- Regina Shih has been selected for inclusion in Marquis Who's Who. As in all Marquis Who's Who biographical volumes, individuals profiled are selected on the basis of current reference value. Factors such as position, noteworthy accomplishments, visibility, and prominence in a field are all taken into account during the selection process.
With a career spanning more than three decades, Ms. Shih has established herself as a distinguished expert in medical device regulatory affairs. Her storied journey began after she returned to the United States at age 17, bringing with her a strong sense of self-discipline and pride rooted in her Chinese heritage. Fluent in both Mandarin and English, she was influenced by her accomplished family: her father, Dr. So Chao Shih, a leading scientist in Taiwan and led the Taiwan Sugar Institute for 17 years; her brother, Tom I.P. Shih, served as a Chair Professor at Purdue University; and her sister, Judy Yin Shih, holds a Doctor of Philosophy and supports Johns Hopkins University.
Ms. Shih's own professional trajectory reflects her progressive leadership and expertise across the pharmaceutical and medical device industries. Since 2025, she has served as an adjunct professor at Roger Williams University in Bristol, Rhode Island, where she teaches graduate-level students about Pharma and Device regulatory affairs as part of the school's Natural and Social Sciences Department.
Alongside her teaching endeavors, Ms. Shih assumed the role of Vice President of Global Regulatory and Clinical Affairs at CooperSurgical Inc. in Trumbull, Connecticut, where she has built a large global regulatory team recognized for its strong employee engagement and cohesion. Under her leadership, the team has consistently achieved top scores in Gallup surveys and become known as one of the most cohesive functions within the organization. This reputation attracted interest from talents across the industry and agencies to join CooperSurgical due to its high performance and positive culture.
Ms. Shih leads a large team of seasoned Regulatory and Clinical professionals across multiple sites in the United States, United Kingdom and Denmark, with regulatory satellite offices in other Economic Operation regions such as the Asia-Pacific and Middle East. Her responsibilities include strategizing and obtaining market access for company products, ensuring regulatory compliance in global regions, collaborating with cross functional departments to ensure the company's capability of excellence in customer service, quality products deliverance, and compliance status via efficient regulatory processes; all through fostering a highly effective, collaborative, and team-centered culture.
Prior to joining CooperSurgical, Ms. Shih gained valuable leadership experience as Vice President of Quality and Regulatory affairs at Intrinsic Therapeutics Inc. in Woburn, Massachusetts, following her initial tenure as Vice President of Global Quality and Regulatory affairs at Beaver-Visitec International (BVI) in Waltham, Massachusetts.
Prior to assuming the Vice President role, Ms. Shih was the Senior Director of Regulatory Affairs and Quality Assurance for North Asia at CR Bard Inc. in Murray Hill, New Jersey, Ms. Shih managed global operations across China, Japan, Korea, Taiwan and Hong Kong. She is particularly proud of successfully reorganizing the CR Bard China team, which involved transforming the previous undermining culture into one marked by enhanced cross-cultural understanding and organizational effectiveness. As a Chinese-American leader, she bridged crucial cultural gaps and handled complex personnel cases that contributed to long-term improvements.
Ms. Shih's earlier roles in Regulatory Affairs equipped her with valuable experience across companies in medical devices encompassing wound care, dialysis, spinal implants; as well as pharmaceuticals, at leading entities like Johnson & Johnson, Exactech, Covidien and Fresenius Medical Care, etc. throughout the 1990s and 2000s.
To share insights and stay aware of best practices, Ms. Shih is an active member of AdvaMed (Advanced Medical Technology Association), RAPS (Regulatory Affairs Professional Society) and OSMA (Orthopedic Surgical Manufacturing Association).
Hailing from an equally accomplished academic background, Ms. Shih earned a Master of Business Administration, with a focus in organizational leadership from University of Massachusetts Dartmouth in 2019; a Master of Science in food engineering from The Pennsylvania State University in 1993; and a Bachelor of Science in agriculture from the University of Florida in 1990. Also expanding her horizons through writing, she has co-authored multiple articles for professional journals on topics related to microwave heating and NIR spectroscopy technology. Along with her education, she attributes her success to self-discipline and endless curiosity to pursue new interests, which values instilled in her from an early age, feeling a deep responsibility to honor her family's legacy through excellence and the empowerment of others.
Beyond her professional roles, Ms. Shih is known for her contributions as a civic-minded citizen — particularly for vulnerable populations. At both Intrinsic Therapeutics and CooperSurgical Inc., she has led charity initiatives in support of centers for the elderly and shelters for women in need.
Ms. Shih's exceptional achievements have seen her recognized with several accolades over the years, including the Outstanding Leadership Award from CooperSurgical in 2023 as well as the Johnson & Johnson Global Leadership Award in 2006. Earlier in her journey, she was presented with the Research & Development Special Recognition Award from Tyco Healthcare (former name of Covidien) in 2001.
As a balance to her professional responsibilities, Ms. Shih maintains an active lifestyle by playing piano, composing music, playing tennis and practicing karate / Tai Chi. Also happily married and a proud mother, she has successfully raised two children from a previous marriage.
Looking toward the future, Ms. Shih intends to transition into consulting / teaching while continuing her full-time work. She aims to give back by coaching those within her team at CooperSurgical as well as industry colleagues and university students about regulatory affairs. Additionally, she aspires to publish a book that bridges critical gaps between industry practices and regulatory bodies, furthering education on the evolving landscape of medical device regulation.
About Marquis Who's Who®:
Since 1899, when A. N. Marquis printed the First Edition of Who's Who in America®, Marquis Who's Who® has chronicled the lives of the most accomplished individuals and innovators from every significant field of endeavor, including politics, business, medicine, law, education, art, religion and entertainment. Who's Who in America® remains an essential biographical source for thousands of researchers, journalists, librarians and executive search firms around the world. The suite of Marquis® publications can be viewed at the official Marquis Who's Who® website, www.marquiswhoswho.com.
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