James Wabby

1st January, 1970

James Wabby

Over 15 years of experience in increasing regulatory affairs and quality compliance responsibilities within the GxP regulated environment pertaining to Medical Device, Digital Medicine and Combination Product areas.

Regularly provides Allergan 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


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Speaker opportunities

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