Karen Hyland

Senior Manager of Regulatory Affairs


Karen Hyland is a Senior Manager of Regulatory Affairs at Medtronic’s Center of Excellence for Operations and R&D at Parkmore Galway, Ireland. In this role she leads a diverse regulatory team involved in the development and implementation of global regulatory strategies for various medical devices and combination products. She is also part of the site Operations Leadership Team focused on implementation of manufacturing strategies in support of multiple businesses for Medtronic across the Cardiac and Vascular Group.


Karen has a Bachelor of Science from National University of Ireland, Galway and a Master of Science from University of Ulster. She has over 15 years industry experience working in medical device industries including a clinical research organisation. She interfaces with numerous regulatory authorities including US FDA, Notified Bodies and Competent Authorities in addition to the large Medtronic community around the globe. Karen has a keen interest in evolving regulatory frameworks, recognising the role of regulatory affairs in providing strategic leadership to influence the global regulatory environment in order to benefit the patients we serve.

All Speakers