vi Regulatory Affairs Professionals Society (RAPS)
Isabella Schmitt, MBA, RAC-Devices
Vice President of Regulatory and Clinical
Affairs
HeartSciences, Inc
Vishal Shiralkar, RAC-Devices, PMP
Global Regulatory Labeling Manager
ZOLL Medical Corporation
Sharad Mi. Shukla, MS, RAC-EU, RAC-
US
Director Regulatory Affairs
Johnson &Johnson MedTech
Steve Silverman, Esq., JD
President
The Silverman Group
Sue Spencer
Director
Compliance Connextions Limited
Beat U. Steffen, MSc, MBA, RAC-Devices,
FRAPS
Founder &Chairman
confinis ag
Kevin G. Stevens, MS, RAC-US
Head of Regulatory Affairs for Digital and
Devices, PDT
Takeda Pharmaceuticals
Farzin Miralireza Takyar, MD, PhD
Assistant Professor
Research Institute for Endocrine Sciences
Amy Tezel, PhD
Senior Executive Scientific Strategist
3D Communications
Jackie Torfin, MA, CQA (ASQ)
CEO, Principal Advisor
QLeaR Advisors
Kimberly A. Trautman, MS
Medical Device, IVD and Combination
Product Expert
Jay Y. Vaishnav, PhD, RAC-Devices,
FRAPS
Director of Regulatory Affairs
Canon Medical Informatics, Inc.
Richard A. Vincins, RAC-Devices
Principal Strategy Consultant
NAMSA
James P. Wabby, MHMS
Head, Global Regulatory Affairs (CoE) -
Combination Products
AbbVie Inc.
Xueke Wang, PhD, RAC-Devices
Technical Leader of Human Factors
Fresenius Medical Care
Yu-Wen Wang, PhD
Principal Consultant, Regulatory Affairs
and Quality Assurance
Mediqwise Regulatory &Quality
Stephen C. Weber, MD
Expert Consultant
NDA Partners
Liang Xu, MEng, RAC-Devices, RCC-
MDR, RCC-IVDR, PMP
Lead auditor
Intertek
Silu (Lulu) Zhang, MS, RCC-MDR, RCC-
IVDR
Head of Global Regulatory Affairs and
Quality Assurance
O-Two Medical Technologies Inc.
Karen Zhou, JD, MS, RAC-Devices,
RAC-Global
Professor
Northeastern University
Jocelyn Zhu, MBA
COO
TX Medical