v
Mark Durivage, MS, RAC-Global
Managing Principal Consultant
Quality Systems Compliance LLC
Karen Fan, MSc, RAC-CAN, RAC-EU,
RAC-US, PEng, PMP
EU MDR Regulatory Consultant
Johnson &Johnson MedTech Vision
Yuan Fang, PhD, MBA, RAC-US
Divisional Vice President, Global Strategic
Regulatory
Abbott Laboratories
Aikaterini Monika Fiorevanti, MBA, MSc
Borderlines Lead
Medicines and Healthcare products
Regulatory Agency
Zillery A. Fortner
Industry and Business Development,
Director, SME
Honeywell
Anu Gaur, PhD, MBA, MS, RAC-Global,
RAC-US
President
SYNERGY Global Regulatory Affairs
Consultancy, Inc.
Elizabeth Goldstein, RAC-US
Director, Regulatory Affairs
Endologix
Sandra Ligia González Aguirre
Executive Secretary
Inter-American Coalition for Regulatory
Convergence, Medical Technology Sector
Surina Gulati, MBEE
Senior Quality Systems &Compliance
Engineer
Align Technology Inc.
Melissa Hall, MS
CEO and Principal Consultant
Statera Regulatory Consulting
Lisa G. Hawkins
Senior Vice President of Quality
Katelin Henninger, MS, RAC-Devices,
RCC-MDR
Manager, Regulatory Affairs, NA Pharma
Aptar Pharma
Nickerson Hill
Vice President, Global Regulatory Affairs
LivaNova
Elizabeth Trautman Hillsley, MS
Senior Design Quality Engineer
Paragonix
Irene Hsieh, MS
Senior Director, Regulatory Affairs and
Quality Assurance
ClearNote Health, Inc.
Christie Hughes, MPH, MLS(ASCP),
RCC-IVDR
Director of Regulatory and Compliance
Goldbug Strategies
Lauren E. Jackson
Program Manager, Regulatory Affairs
Dexcom Inc.
Jocelyn Jennings, MS, RAC-US, RAC-
Drugs, RAC-Devices, FRAPS
Vice President, Regulatory Affairs and
Quality Assurance
Mycovia Pharmaceuticals, Inc.
Donielle D Johnson, MS
Senior Director Regulatory Affairs
Baxter
Sumatha Kondabolu, MSc
Senior Quality Business Partner
Qualio, Inc.
Carrie M Kuehn, DLP, MA, MPH,
RAC-US
Founder &Principal Consultant
Evergreen Strategic Consulting, LLC
Akanksha Kulshreshtha, PhD, MS,
RAC-Devices
Manager, Regulatory Affairs
FUJIFILM Sonosite, Inc.
Huiyang Li, PhD
Senior Staff Fellow
Food and Drug Administration
Daniele Lioi, PRRC
Senior Consultant -Medical Devices and
Business Unit Manager
Eurofins
Bianca Lutters, PhD
Head of Clinical Operations
Qserve Consultancy BV
Ricky (Ruiqi) Ma, PhD
R&D Fellow
Boston Scientific Corporation
Deborah Morley, PhD
President and Principal Consultant ALM
Premier MedDev LLC
Tina O’Brien, MSc, RAC-US, RCC-MDR
Director of Global Regulatory Affairs
Paragon 28
Melissa R. O’Connor, MS, RAC-Devices,
FRAPS
Chief Quality &Regulatory Officer
StimLabs, LLC
Gerry O’Dell, MS
Co-owner &Technical Director
O’Dell &Hodge Consulting, LLC
Rutvik Patel, MS
Executive Director
Quolis Global Inc.
Sharon Perez, PhD
Vice President, Global Medical Safety
Novocure
Shruti Prakash, MS, RAC-Devices
Principal Regulatory Affairs Specialist
Medtronic
Karina Valbuena Reyes, MSc Eng.
Quality Assurance and Regulatory Affairs
Manager
Caroline Rhim, PhD
Founder &Principal Consultant
Evera Regulatory Advisors, LLC
Suzanne Richardson, MSc, RAC-Drugs,
RAC-US
Founder
PreSpectives LLC
John Rossman, MBEE, PMP
Director, Regulatory Affairs
Stryker