Kerri Austin

Kerri Austin is a strategic Regulatory Affairs Certified (RAC) medical device professional with experience in Canadian, US, and EU markets. Kerri has led the medical device lifecycle approval processes via advising on regulatory strategy, facilitating pre-submission meetings, managing clinical trials, and medical device authorisations. She has 20+ years of experience working with various types and classes of devices including in vitro diagnostic devices (IVDDs), high risk implantable (i.e., active and non-active), medical software/apps, remote monitoring, diagnostic, advanced mapping/navigation, and ablation systems.

Kerri is experienced in teaching college post-graduate regulatory affairs courses, along with, designing and delivering corporate training for onboarding or ongoing compliance. Kerri sits on a College Digital Health Professional Advisory Committee and is a Regulatory Affairs Mentor and FemSTEM Mentor within the Health Innovation Hub at the University of Toronto.