Nicole Kotter

Nicole Kotter is an experienced regulatory affairs professional with a robust background in the medical device industry. Serving as Director at Integra LifeSciences from July 2017 to April 2023, Nicole provided strategic leadership for a mid-size team, overseeing product introductions and regulatory compliance initiatives for the Tissue Technologies Division. Responsibilities included managing original PMA applications and regulatory activities for multiple manufacturing sites, along with leading a team in compliance and technical documentation efforts in previous roles as Senior Manager and Manager. Prior experience includes positions at the University of Virginia and NASA Goddard Space Flight Center, complemented by an MBA with a focus on International Business and Strategic Management from Villanova University and a BS in Biomedical Engineering from the University of Virginia.