Joanna McCarthy
Joanna McCarthy, MedTech Consultant, Global Clinical Regulatory Affairs
Joanna's background in Industry is mixed having supported both Pharma (Lilly) and medical technology companies (Stryker/Trinity Biotech) based in Ireland to develop their R&D clinical regulatory strategies at a Global level.
She has worked in the medical technology industry for over 13 years and was formerly the SME for the Neurosurgical Business Unit at Stryker Instruments for clinical regulatory requirements through EU MDR execution. In her last role, Joanna was Associate-Director Clinical Regulatory & Global Regulatory Affairs at Lilly, where she led a multi-disciplinary team of scientists through the Late Phase approval of an IBD - Biologic Drug in North America and Latam. She was also responsible for a large Pediatric IBD program of 5 post market commitment studies in the US.
Joanna has a key interest for building novel clinical regulatory strategies to gain faster market access globally. Her focus is mainly in the areas of high-risk Class III neurosurgical devices, electrosurgical devices and drug-device combination products.
She was heavily involved within the Irish MedTech Association through EU MDR regulation changes having presented on state-of-the-art and PMCF requirements for clinical evaluations while being an active member of the clinical task force for a period of 5 years.