James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Nutritional, Cosmetic, Branded Pharmaceutical, Generic, Biologic, Medical Device and Combination Product areas. James received his undergraduate and graduate degrees from Duquesne University and received his Health Care Compliance Certificate from Seton Hall University Law School. He is a member of various regulatory and quality work groups including RAPS, OCRA and the ASQ Orange Empire Section.

Experienced Medical Devices, IVD and Combination Product Expert with over 40 years of experience, including 24 years working at the U.S. FDA CDRH. Author of the 1996 Medical Device Quality System regulation and member of the authoring group for Combination Product GMPs in Part 4. US Expert on GHTF and IMDRF 1991-2016, working with Regulatory Agencies around the globe. At FDA conceived and developed the Medical Device Single Audit Program (MDSAP) and in the private sector opened an Auditing Organization and a new Notified Body in Ireland for EU IVDR/MDR Designation. Executes regulatory and QMS services to include consulting, auditing, and education. Masters degree in Biomedical Engineering.