James Wabby, MHMS is Executive Director of Regulatory Affairs, focusing on Emerging Technologies and CMC-Device at AbbVie, based in Irvine, CA. Wabby has over 15 years of experience in many facets of regulatory affairs, quality compliance and quality operations within the GxP regulated environment pertaining to Medical Devices, Combination Products, and Digital Medicine.
Wabby 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.
Wabby received a certificate in Health Law and Life Science Compliance from Seton Hall University Law School, (MHMS) in Health Law and Policy from Duquesne University and a (BSc) in Biological Sciences from Duquesne University. He is a member of various regulatory and quality work groups including DIA, RAPS, AAMI, AHLA and the ASQ Orange Empire Section. In addition, Wabby lectures at various symposia, is the Chairman of the DIA Combination Products Committee, chairs various global combination products conferences and participates in panel discussions within the industry. Wabby_James@Allergan.com