Kelsey Lee
Built her career inside the world’s most influential medical technology companies, including Medtronic, Invitae, and Stryker. There, she didn’t just manage compliance—she shaped it.
Kelsey Lee
About Kelsey
Kelsey Lee has spent more than 16 years navigating the complex intersection of medical device innovation and global regulatory strategy.
Known as one of the country’s most respected regulatory minds, she’s led submissions and strategies for everything from orthopedic implants to ventilators, patient monitors, SaMD, and in-vitro diagnostics (IVDs).
What sets Kelsey apart is her philosophy: regulatory isn’t a barrier — it’s a design tool. She believes compliance and creativity go hand-in-hand, and her strategic approach allows startups and established manufacturers alike to reach the market nearly 40% faster.
With her leadership, Boulder Solutions is redefining how medical devices are developed — seamlessly integrating regulatory thinking from concept to commercialization.
Kelsey has consistently led regulatory submissions that achieved market clearance through the FDA. These approvals represent years of strategic leadership, detailed documentation, and coordination across engineering, quality, and product teams — proof of her ability to deliver real-world results that meet the highest regulatory standards.
Education & Experience
Education
The University of Akron
Concentration: Biomechanics
