Katlyn Kachman

Katlyn Kachman is an accomplished regulatory affairs professional with extensive experience in the medical device industry. Currently serving as a Sr. Regulatory Affairs specialist at ICU Medical, Katlyn previously held the position of Regulatory Affairs Specialist at Philips and Director of Quality at Genicon, Inc. Noteworthy achievements include assisting in the successful review of quality systems compliant with ISO 13485 and 21 CFR 820, obtaining two FDA 510k approvals, and integrating document control processes that increased productivity by 50%. Katlyn has demonstrated a strong ability to manage regulatory approvals across over 50 countries, improve response times, and conduct vendor audits, contributing to significant business growth and compliance excellence. Katlyn holds an MBA and a degree in Business Administration with an Entrepreneurship Track from UCF College of Business.