Speaker List

Senior Consultant
AKRA Team

Belgium

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

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

Executive Director & Partner
Qserve Group

Vice President
QualityHub, Inc.

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

Vice President, Regulatory Affairs
STERIS Corporation

Ohio, United States

Sr. Director of Quality Assurance
West Pharmaceutical Services

Vice President, Quality
Flex Health Solutions

Partner
Arnold Porter

Vice President of Quality Systems & Post Market
Boston Scientific

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

Sr. Advisor and Head of Quality Compliance
Brooke & Associates

Ohio, United States

Chief Scientific Officer
Pathway for Patient Health

Lead Quality Systems Auditor
Fresenius Medical Care

Subchapter Lead, Product & Service Partnering
Roche Diagnostics

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

Pennsylvania, United States

Director of Global Design
Boston Scientific

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

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

President & CEO
Medical Device Manufacturers Association (MDMA)

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

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

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

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, Regulatory Affairs
STERIS Corporation

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

Director
ERA Sciences

Chief Quality Officer
Johnson & Johnson

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

Senior Director, Regulatory Affairs
STERIS Corporation

Ohio, United States

CEO and Principal Consultant
FDA Rescue

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

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

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

Partner
Arnold & Porter

Executive VP, Medical Devices and Combination Products
Eliquent Life Sciences

Senior Vice President, Regulatory and Quality
TUV SUD

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

Expert
Medical Device, IVD and Combo Product Expert

Virginia, United States

Attorney-at-law
Axon Lawyers

Global Regulatory Policy & Advocacy Associate Director
Boston Scientific

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

Director, Quality Business Support
Abbott

VP Regulatory, Quality & Compliance
Abbott

Illinois, United States

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

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

Vice President, Quality, & Regulatory Counsel,
Edwards Lifesciences