John Kilmartin

Medtech Regulatory Consultant & Adjunct Professor, University of Galway (Inst. for Clinical Trials), Ireland

John Kilmartin – Adjunct Professor at the Institute for Clinical Trials (University of Galway, Ireland) and independent MedTech Regulatory Advisor.

John is an Adjunct Professor at the Institute for Clinical Trials (University of Galway, Ireland) where he is focused on the opportunity for clinical trial infrastructure for innovative medical technologies in Europe/Ireland.

He is also an Associate Adjunct Professor in Trinity College Dublin (Regulatory Affairs) and has been a strong advocate for the development of third level education in Regulatory Affairs and Clinical Affairs.

He is an independent MedTech executive with Kilmartin MedTech Partners who support medical technology companies to develop their regulatory, clinical and market access strategies and is also working as an Advisor to a number of organizations in the LifeSciences and Training/Education environments.

John has worked in the medical technology industry for over 30 years with particular emphasis on US, European and emerging market regulatory frameworks. His last industry role was Vice-President of Regulatory Affairs in Medtronic where he led a global team of Regulatory professionals who developed and executed on regulatory strategies with US FDA, European Notified Bodies and other international regulators. He has a particular interest in high-risk Class III cardiovascular devices, catheter-based technologies and drug-device combination products.  In addition, he has a strong interest in the evolving regulatory frameworks that continue to develop across the globe.

John has been involved with various industry associations including MedTech Europe, Advamed and the Irish MedTech Association (IMA).  He was Chair of the IMA Regulatory Steering Committee for a number of years.

John has always had an active interest in the development of the next generation of Regulatory Affairs/QA professionals and helped develop various third level courses on Regulatory Affairs/QA and Clinical Affairs for Medical technologies. He is a graduate of both the University of Galway and the Royal College of Surgeons RSCI in Dublin.