Stephanie Loots

Stephanie Loots is a Regulatory Affairs Professional at W. L. Gore & Associates since July 2021, serving as the primary regulatory liaison for Class III implantable infrarenal aortic products generating $0.75 billion in annual revenue and providing global regulatory strategy for new product development. Previously, Stephanie held roles as a Senior RA Specialist at Invitae and ArcherDX, focusing on international regulatory strategy for Class C diagnostic devices and leading a team in compliance efforts related to EU IVDR. Additional experience includes supporting regulatory compliance for Class I and II products at Covidien and maintaining quality system compliance at Bio2 Medical, along with early career experience as a researcher and teaching assistant at the University of Colorado Boulder. Stephanie holds a Bachelor of Arts in English Language and Literature with a focus on Creative Writing from the University of Colorado Boulder.