Kerri Austin, Senior Regulatory Affairs Manager at ICON plc.
Kerri Austin is a medical device regulatory professional with 20 years of regulatory and compliance experience in Canadian, US and EU markets. In her consulting role at ICON, Kerri leads the Canadian medical device lifecycle approval process via advising on regulatory strategy, facilitating pre-submission meetings, special access, managing regulatory submissions for pre-approval (clinical trials) and medical device approval. Kerri has strategically navigated the successful Canadian registration of unique first to market devices, leveraging the priority review process for multiple device portfolios in Canada. 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 has worked over a decade at St. Jude Medical (now Abbott Medical) on the cardiovascular and neuromodulation portfolios. While at Abbott Medical, she managed a globally marketed medical device portfolio, including new product development to commercialization.