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Kristin Casper, RAC, has extensive experience in quality assurance and regulatory affairs within the medical device industry, currently serving as the Director of Quality Assurance and Regulatory Affairs at BioFire Defense since July 2015. Previous roles at BioFire Defense include Associate Director of Quality Assurance & Regulatory Affairs and Regulatory Specialist 3. Prior to joining BioFire Defense, Kristin worked at ICU Medical from October 2008 to July 2015 as a Senior Regulatory Affairs Specialist, where responsibilities included managing 510k submissions, international product registrations, and maintaining compliance with the Medical Device Directive (MDD). Kristin holds a Bachelor's degree in Health, Society and Policy from the University of Utah.