Kelsey Candelmo

Kelsey Candelmo is a Senior Regulatory Affairs Specialist at Guardant Health, where responsibilities include assisting in the submission of an original FDA premarket approval application and leading PMA supplement activities. With previous experience as a Regulatory Affairs Specialist at both Mueller Sports Medicine and Guardant Health, Kelsey has developed expertise in regulatory submissions, facility compliance, and lifecycle management of medical devices. Professional background also includes quality assurance roles at PPD and Covance, focusing on compliance with GMP and GLP regulations. Kelsey holds a Bachelor's Degree in Biology from the University of Wisconsin-Madison, enhancing a strong foundation in regulatory affairs and quality management in the medical and pharmaceutical sectors.