Kerri Austin

Kerri Austin (Senior Regulatory Affairs Manager at ICON plc) is a Regulatory Affairs Certified (RAC) strategic medical device professional with regulatory and compliance experience in Canadian, US, and EU markets. In her current role, Kerri leads the medical device lifecycle approval processes via advising on regulatory strategy, facilitating pre-submission meetings, managing clinical trials, and medical device authorisations. She has worked with various types and classes of devices including in vitro diagnostic devices (IVDDs), high risk implantable (i.e., active and nonactive), medical software/apps, remote monitoring, diagnostic, advanced mapping/navigation, and ablation systems.

Kerri previously worked on Abbott’s cardiovascular and neuromodulation portfolios and has sat on a College Digital Health Professional Advisory Committee. She 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.