2024 MedCon Speakers & Moderators
MedCon speakers are hand-selected by the MedCon Strategic Committee to deliver purpose-driven content that dives below the surface, challenges status quo, engages attendees in collaborative dialogue, and provides practical information that can be implemented. Our speakers are thought leaders who are sure to facilitate insightful discussions.
Deputy Director, Office of Clinical Evidence and Analysis, Center for Devices and Radiological Health (CDRH)
Senior Director of Regulatory Strategic Planning for Cybersecurity at BD
Executive Director & Partner at Qserve Group
Director for the Office of Regulatory Programs Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Director for the Compliance Branch Division 1/East, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the Food and Drug Administration
Senior Director of Regulatory Affairs at STERIS Corporation
Jason Brooke
Brooke & Associates
Attorney & Managing Member at Brooke & Associates
Vice President, Digital Health, AI & Radiology
Director for the Office of Clinical Evidence and Analysis, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Associate Director of Strategic Development, Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Paul Coplan
Johnson & Johnson Medtech
Vice President and Global Head, Medical Device Epidemiology
Consumer Safety Officer, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA)
Heidi Dohse
Tour de Heart
Founder and President at Tour de Heart
Aaron Dunbar
Boston Scientific
Vice President Quality Systems & Post Market at Boston Scientific
Regulatory Officer for the Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Deputy Director for the Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Katie Furtick
Boston Scientific
Principal Quality Systems Engineer
Quality Assurance & Global Quality Systems at Cook Medical
Consumer Safety Officer, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA)
General Manager of Medical Devices at Anvisa
Biomedical Engineer for the Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Alissa Hanna
Edwards Lifesciences
Director of Patient Engagement at Edwards Lifesciences
Kristen Hastings
Haemonetics
Director of Design Quality
Cybersecurity Policy Analyst, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Eric Henry
King & Spalding
Senior Quality & Regulatory Compliance Advisor at King & Spalding LLP
Sabina Hoekstra -van den Bosch
TÜV SÜD Medical Health Services
Global Director, Regulatory Strategy
Shannon Hoste
Pathway for Patient Health
diane johnson
Johnson & Johnson MedTech
Senior Director, North American Policy, Lead
Senior Advisor, Compliance and Quality Program, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Director, Regulatory Strategy at Medtronic
Tina Krenc
KTA Compliance Consulting
Principle Consultant at KTA Compliance Consulting
President & CEO at Medical Device Manufacturers Association (MDMA)
Senior Advisor for Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the Food and Drug Administration
CSO Special Assistant for Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the Food and Drug Administration
Simon Mason
NESTcc part of MDIC
Senior Director of Global Technologies at Steris Group
Deputy Program Director, Medical Device and Radiological Health Operations, (OMDRHO), Office of Regulatory Affairs (ORA)
Sarah Sue Morbitzer
Ohio State University
Volleyball Player at Ohio State University
Director of Premarket Operations, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Regulatory Policy Advisor, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Digital Health Associate Director for the Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Yarmela Pavlovic
Medtronic
Vice President, Global Regulatory Affairs, Strategy & Policy
Medical Device Senior Operations Officer, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA)
Medical Device Compliance Officer for the Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the Food and Drug Administration
Investigator, Medical Device National Expert, Division of Medical Products and Tobacco Program Operations Branch, Office of Regulatory Affairs (ORA)
Public Health Service Supervisory Investigator for the Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the Food and Drug Administration
Fatemeh Razjouyan
Medtronic
Director of Regulatory Policy, International and Harmonization, Global Regulatory Policy at Medtronic
Program Director for the Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the Food and Drug Administration
Vice President of Global Market Segment Leader-Medical Device at Nelson Labs
Heather Rosecrans
Greenleaf Health
Executive Vice President of Medical Devices & Combination Products at Greenleaf Health
Deputy Director for the Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
Division Recall Coordinator Division I/East, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA)
Senior Director of U.S. Regulatory and Global Digital Health Policy at Medtronic
Kim Shoemaker
Johnson & Johnson
Sr. Director of Global Regulatory Affairs at Ethicon
Director of the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Director for the Office of Strategic Partnerships & Technology Innovation, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Global Head of Regulatory Policy, Foundational Principles, and Supranational Organizations at Roche
Director of Compliance and Quality, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Medical Device, IVD and Combo Product Expert
Associate Director of International Affairs, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration
Director, Regulatory Affairs
Colleen watson
Thermo Fisher Scientific
Senior Director, Regulatory Affairs
VP of Regulatory and Quality at Abbott
Jessica Zeller
Edwards Lifesciences
Vice President of Quality, Regulatory, Environmental, and Public Affairs Counsel at Edwards Lifesciences