James Wabby, BSc., MHMS, is the Head, Global Regulatory Affairs, Center of Excellence (COE) – Emerging Technologies and Combination Products & Volwiler Senior Research Industry Fellow – Regulatory Science at AbbVie Inc.
James is a Regulatory Science visionary and cross-discipline key opinion leader with 22 years of experience in increasing regulatory affairs, quality operations, and regulatory compliance responsibilities within the GxP regulated environment pertaining to Medical Devices, Medicinal Device Delivery Platforms, Complex Generics, Companion Diagnostics, Digital Medicine, and Combination Product areas.
Regularly provides AbbVie therapeutic franchise units regulatory counsel and strategy to all aspects within the quality management system and regulatory affairs regarding CMC Global Dossiers and Global Device Regulatory Strategies, EU MDR/IVDR –Person Responsible for Regulatory Compliance (PRRC), 21 CFR Part 3 and Part 4 -Combination Products, CE Marking, ISO 13485:2016/MDSAP, International Regulatory Affairs, Product Development -(Design Control, Risk Management and Human Factors Engineering), Acquisitions/Divestitures and represents AbbVie as the U.S Agent regarding FDA matters for international medical device facilities. Furthermore, he actively participates in industry trade organizations and is on standards committees.
Futhermore, he is an internationally recognized leader, speaker, chair, and keynote at various regulatory symposia, Chairman of the DIA Combination Products Committee, moderator for various global regulatory panel discussions, and has various publications, interviews, and podcasts. In addition, he is an Adjunct Assistant Professor at the University of Southern California (USC) – School of Pharmacy – Regulatory and Quality Sciences.
He holds a BSc. in Biology from Duquesne University, MHMS in Health Law and Policy from Duquesne University, Certificate in Health Law and Life Science Regulatory Compliance from Seton Hall University Law School – Center for Health & Pharmaceutical Law, and Certificate, RAPS Executive Development Program from Northwestern University – Kellogg School of Management.
He is a member of various regulatory and quality work groups including DIA, RAPS, ISPE, FDLI, PDA, AAMI, AHLA and the ASQ Orange Empire Section. In addition, lectures at various symposia, is the Chairman of the ISPE Combiantion Products Committee, DIA Translational Device Technologies and Precision Medicine Committee, chairs various global combination products conferences and participates in panel discussions within the global industry. James.Wabby@abbvie.com