Speaker List

Senior Fellow, Corporate Clinical Quality
Boston Scientific

Strategic Facilitator
AFDO/RAPS Healthcare Products Collaborative

Captain
Grandview Heights Division of Fire

Ohio, United States

Divisional Vice President Quality
Abbott

Executive Director & Partner
Qserve Group

Vice President
QualityHub, Inc.

Technical Director - Medical Audit
SGS North America Inc.

Vice President, Regulatory Affairs
STERIS Corporation

Ohio, United States

Principal
Claverie & Associates Consulting, LLC

Maryland, United States

Vice President of Quality Systems & Post Market
Boston Scientific

Principal, Quality & Compliance
Eliquent Life Sciences

District of Columbia, United States

IVD and MDSW Expert
ACT-IVD

Alberta, Canada

VP Strategic Sourcing
Edwards Lifesciences

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

Corporate Director, Quality Assurance & Global Quality Systems
Cook Medical

Indiana, United States

Associate Director of Regulatory Affairs
Johnson & Johnson MedTech

Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice
King & Spalding LLP

Global Director Regulatory Strategy
TÜV SÜD Medical Health Services

Chief Scientific Officer
Pathway for Patient Health

Senior Product Manager
ISACA

Materials Engineer, Compliance and Quality Program, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA (Virtual)

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)

General Manager – Quality Systems
Fisher & Paykel Healthcare

Executive Director
Association of Food and Drug Officials (AFDO)

Risk Management Engineer
Eli Lilly and Company

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

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 (Virtual)

Vice President US Operations and Principal Consultant
Qserve Group

Executive Director
Regulatory Affairs Professionals Society, RAPS (Welcome)

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

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

Director, Regulatory Affairs
STERIS Corporation

Senior Director, Quality
Illumina

Director of Quality and Regulatory
KeborMed

Head of Pre-Market Approval of Medical Device
Anvisa - Brazil

Principal Consultant
BioTeknica

Florida, United States

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

Director of Regulatory Affairs
STERIS Corporation

Ohio, United States

Retired, FDA

Director of Regulatory Policy, International and Harmonization | Global Regulatory Policy
Medtronic

Senior Director of Cybersecurity Policy, Global Regulatory Affairs
Medtronic

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

Executive Vice President, Medical Devices & Combination Products
Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA

Principal, Medical Devices & Combination Products
Eliquent Life Sciences

Senior Director, Global Regulatory Affairs
Johnson & Johnson MedTech

Associate Medical Device Consultant
MEDIcept

Chairman and CEO
T2 Biosystems, Inc.

Massachusetts, United States

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

United States

Global Head of Regulatory Policy, Foundational Principles and Supranational Organizations
Roche

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

Expert
Medical Device, IVD and Combo Product Expert

Chief Regulatory, Quality, Clinical Officer
GT Metabolic Solutions, Inc. (virtual)

Minnesota, United States

Senior Manager, Post Market Surveillance Team
Zimmer Biomet

Director Quality
Abbott

VP Regulatory, Quality & Compliance
Abbott

Illinois, United States

Chief Security Strategist
MedCrypt

Independent Expert
MLZ Biotech Consulting Inc

Vice President, Quality, & Regulatory Counsel,
Edwards Lifesciences