AFDO RAPS Healthcare Products Collaborative
BIO
James Wabby

James

Wabby

Global Head - Emerging Technologies, Combination Products, and Devices

AbbVie

With 20+ years of experience, specialized in quality operations, compliance, and regulatory affairs across Medical Devices, Technology Medicinal Delivery Platforms, Complex Generics, Companion Diagnostics, Digital Medicine, and Combination Products. Provide strategic regulatory counsel to AbbVie franchise units and expertise in CMC Global Dossiers, EU MDR/IVDR compliance, 21 CFR Part 3 and Part 4, CE Marking, and ISO 13485:2016/MDSAP. Represent AbbVie as U.S. Agent for FDA matters. Active involvement in industry trade organizations and standards committees.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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