Kerri Austin, Senior Regulatory Affairs Manager at ICON plc.
Kerri Austin is 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, 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 provide regulatory training for onboarding and/or ongoing compliance needs.
Kerri sits on Mohawk College’s Digital Health Professional Advisory Committee, teaches at Algonquin College and is a Regulatory Affairs Mentor and FemSTEM Mentor within the Health Innovation Hub at the University of Toronto.