Kristi Kistner Amgen, Inc.

Kristi Kistner has over twenty-five years professional experience in medical devices. She has focused on device constituent parts of combination products for the last five years at Amgen, where she is an Executive Director of Regulatory Affairs. Kristi is an active participant in standards development through membership in AAMI and ISO/TC committees and participates in other external organizations working toward clarity/harmonization of combination product development and filing requirements.

Kristi holds a Bachelor of Science in Biomedical Engineering from the University of Southern California, is Regulatory Affairs Professional Society (RAPS) RAC certified in US and EU regulations, and is an American Society for Quality (ASQ) Certified Biomedical Auditor (CBA). Prior to working at Amgen, she was a regulatory affairs consultant and provided RA/QA support to medical device companies globally.