Kerri Austin

Kerri Austin is a Regulatory Affairs Certified (RAC) strategic medical device professional with 20+ years of regulatory and compliance experience, including over a decade at Abbott Medical (formerly St. Jude Medical). In her current role as a Sr. Manager Regulatory Affairs at ICON, Kerri leads the Canadian medical device lifecycle approval process via advising on regulatory strategy, facilitating pre-submission meetings, managing clinical trials and medical device licensing. She has worked with various types and classes of devices including in vitro diagnostic devices (IVDDs), high risk implantable (active and nonactive), medical software/apps, remote monitoring, diagnostic, advanced mapping/navigation, and ablation systems.

Kerri is also uniquely positioned to design, develop, and implement regulatory training for onboarding and/or ongoing compliance needs. Kerri sits on Mohawk College’s Digital Health Professional Advisory Committee, teaches post-graduate regulatory affairs courses, and is a Regulatory Affairs Mentor and FemSTEM Mentor within the Health Innovation Hub at the University of Toronto.