Kelley Breheim
About Kelley Breheim
Kelley Breheim is the Sr. MDR Regulatory Project Manager at Teleflex Incorporated, with extensive experience in regulatory affairs within the medical device industry.
Current Role at Teleflex Incorporated
Kelley Breheim currently serves as the Sr. MDR Regulatory Project Manager at Teleflex Incorporated. Since June 2020, she has been leading efforts focused on MDR (Medical Device Regulation) compliance. Her role involves ensuring that Teleflex's medical devices meet stringent regulatory standards, a critical function for the company's market presence and product safety.
Previous Experience at Coloplast
Before her current role, Kelley Breheim spent four years at Coloplast as the Principal Regulatory Affairs Specialist from 2016 to 2020. Based in Minneapolis, Minnesota, she was responsible for handling complex regulatory tasks, ensuring compliance with U.S. FDA requirements and 21 CFR regulations. Her work at Coloplast contributed significantly to the company's regulatory strategy and compliance.
Professional Stints at Abbott, Boston Scientific, and American Medical Systems
Kelley Breheim also gained significant experience working at Abbott, Boston Scientific, and American Medical Systems in various regulatory roles. In 2016, she was a Senior Regulatory Affairs Specialist at Abbott for five months in Roseville, MN. Prior to that, she served as Principal Regulatory Affairs Specialist at Boston Scientific for eight months and at American Medical Systems for four months in Minnetonka, MN, both in 2015. These roles helped refine her expertise in regulatory affairs.
Career at St. Jude Medical and Medtronic
Kelley Breheim's earlier career includes significant roles at St. Jude Medical and Medtronic. From 2014 to 2015, she was a Senior Regulatory Affairs Specialist at St. Jude Medical for nine months. She spent five years at Medtronic from 2009 to 2014 as a Regulatory Affairs Specialist and one year as a Senior Marketing Specialist from 2007 to 2008. These roles were foundational in her understanding of both regulatory affairs and marketing within the medical device industry.
Educational Background
Kelley Breheim holds an MBA in Marketing Management from the University of St. Thomas, completed between 2002 and 2006. She also earned a BS in Business Administration and French from the University of Wisconsin - River Falls from 1997 to 2001. Her educational background equips her with both strategic marketing insights and a solid foundation in business administration.