James Wabby

Over 19 years of experience in increasing quality operations, quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Medical Device, Digital Medicine and Combination Product areas. In addition, an adjunct assistant professor at USC – School of Pharmacy – Regulatory and Quality Sciences.

Regularly provides AbbVie therapeutic franchise units regulatory counsel and strategy to all aspects within the quality management system arena and regulatory affairs regarding:

  • CMC Global Dossiers and Global Device Regulatory Strategy Registrations
  • EU MDR/IVDR – Person Responsible for Regulatory Compliance (PRRC)
  • 21 CFR Part 3 and Part 4 – Combination Products
  • CE Marking
  • ISO 13485:2016/MDSAP
  • Product Development – Design Controls
  • Risk Management
  • Human Factors Engineering
  • Acquisitions/Divestitures
  • Import/Export – U.S. Agent
  • Production Controls
  • Regulatory Inspection Management
  • Materiovigilance
  • Health-Care Related Laws and International Regulations