Speaker List

Director, Quality Business Support - Software
Abbott

Illinois, United States

VP Regulatory, Quality & Compliance
Abbott

Illinois, United States

Global Head, Regulatory Affairs (CoE) - Emerging Technologies, Devices, and Combination Products & Volwiler Senior Research Industry Fellow - Regulatory Science,
AbbVie, Inc.

Senior Consultant
AKRA Team

Belgium

Partner
Arnold & Porter

Partner
Arnold Porter

Attorney-at-law
Axon Lawyers

Vice President of Quality Systems
Boston Scientific

Global Regulatory Policy & Advocacy Associate Director
Boston Scientific

Sr. Advisor and Head of Quality Compliance
Brooke & Associates

Ohio, United States

Parent of Child with device/Author
Children's Heart Foundation

Pennsylvania, United States

Director
D.K. Kim International Center for Regulatory Sciences at USC Officer

Senior Vice President, Corporate Quality, Regulatory and Clinical
Edwards Lifesciences

Vice President, Quality, & Regulatory Counsel,
Edwards Lifesciences

Executive Director and Site Quality Leader of Indianapolis Device Manufacturing
Eli Lilly and Company

Executive VP, Medical Devices and Combination Products
Eliquent Life Sciences

Director
ERA Sciences

Associate Director of the Resilient Supply Chain and Shortages Prevention, Center for Devices and Radiological Health (CDRH)
FDA

Assistant Director, Establishment Assessment Team 1, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA

Consumer Safety Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
FDA

Medical Device Senior Operator, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Office of Inspections and Investigations (OII)
FDA

Consumer Safety Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Office of Inspections and Investigations (OII)
FDA

Senior Advisor, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
FDA

Consumer Safety Officer, Special Assistant, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
FDA

Assistant Director of Establishment Assessment Team 2, Center for Devices and Radiological Health (CDRH)
FDA

Director, PreMarket Operations, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA

Maryland, United States

Director, Division of Establishment Support, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA

Senior Operations Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Office of Inspections and Investigations (OII)
FDA

Consumer Safety Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Office of Inspections and Investigations (OII)
FDA

Office Director, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
FDA

Medical Device Senior Operations Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Office of Inspections and Investigations (OII)
FDA

United States

Supervisor Consumer Safety Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
FDA

Associate Director for Compliance & Quality, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA

Compliance Officer in Establishment Assessment Team 3, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA

Office Director, Office of Supply Chain Resilience, Office of Strategic Partnership and Technology Innovation (OST), Center for Devices and Radiological Health (CDRH)
FDA (Virtual)

Acting Office Director, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA (Virtual)

Center Director, Center for Devices and Radiological Health (CDRH)
FDA (Virtual)

Senior VP and Consultant
FDA Rescue

CEO and Principal Consultant
FDA Rescue

Vice President, Quality
Flex Health Solutions

Lead Quality Systems Auditor
Fresenius Medical Care

V.P. Regulatory, Quality and Global Strategic Policy
GE Healthcare

Chief Quality Officer
Johnson & Johnson

Executive Vice President, Medical Devices & Combination Products
MDMA & ELIQUENT Life Sciences

President & CEO
Medical Device Manufacturers Association (MDMA)

Expert
Medical Device, IVD and Combo Product Expert

Virginia, United States

Chief Scientific Officer
Pathway for Patient Health

Executive Director & Partner
Qserve Group

Vice President
QualityHub, Inc.

Subchapter Lead, Product & Service Partnering
Roche Diagnostics

Vice President, Regulatory Affairs
STERIS Corporation

Ohio, United States

Director, Regulatory Affairs
STERIS Corporation

Senior Director, Regulatory Affairs
STERIS Corporation

Ohio, United States

Senior Vice President, Regulatory and Quality
TUV SUD

Senior Operations Officer / National Expert, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), (OII)
U.S. FDA, Office of Inspections and Investigations

California, United States

Sr. Director of Quality Assurance
West Pharmaceutical Services