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Thomas McDonagh, MSc

Associate Director Regulatory Affairs
Abbott Core Diagnostics

Tommy McDonagh
Associate Director of Regulatory Affairs
Abbott Core Diagnostics

Tommy McDonagh is an Associate Director of Regulatory Affairs at Abbott Core Diagnostics (based in Sligo Ireland) and has over 20 years industry experience across multiple roles in Quality, Technical Operations and Regulatory. He led the IVDR transition program for the Abbott Core Diagnostics European Manufacturing sites across a broad portfolio of products covering all IVDR product risk classifications. He has recently moved to a new role supporting new product development of IVDs.

As part of his main responsibilities he leads interactions with various regulatory bodies, including Notified Bodies and Competent Authorities. Tommy is an active member of the Irish Medtech Association (IMA) IVD Task Force supporting the IMA QARA Forum and a member of the IMA Regulatory Steering Committee.

Tommy holds a Master’s degree in Biomedical Science from the University of Ulster – Coleraine in Northern Ireland and a Bachelor of Science in Microbiology from the University of Galway, Ireland. He also holds a Project Management Professional (PMP) certification.

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