Global Medical Device Regulatory Strategy
v Regulatory Affairs Professionals Society
Author Acknowledgments
The Regulatory Affairs Professionals Society (RAPS) would like to express appreciation to the following subject
matter experts who shared their experience and knowledge and volunteered their time by contributing to this book.
EDITORS
Peter A. Takes, PhD, RAC-US,
FRAPS
Adjunct Instructor
Washington University
Susumu Nozawa, RAC-EU,
RAC-US, FRAPS
Senior Director, Regulatory
Policy and Standards (TRS &
PREP) – North America
Siemens Healthineers
AUTHORS
Andrea Armando, MS
Vice President, Quality Assurance
and Regulatory Affairs
Diasorin
Gert Bos, PhD, MSc, FRAPS
CSO
Qserve Group
Stanley F. Chalvire, PharmD, JD
Member
Morse, Barnes-Brown &
Pendleton, P.C.
Xianjun Chen, MS
Principal Regulatory Specialist
Smith &Nephew Inc
Philip Desjardins, JD
Partner
Arnold &Porter
Sean D. Detweiler, JD
Partner/Shareholder
Morse Law
Scott D. Dickerhoff, MBA
Retired Regulatory Executive
Dorota Grabowska, PhD
Senior Scientist/Research
Administrator
University School of Medicine in
St. Louis
Shannon Hoste, MSM, MSSE
Founder &Principal Engineer
Hoste Consulting
Thomas Hutchinson, MS,
CQA, CMDA, CMQ/OE,
RAC-US, FRAPS
Principal Consultant
QRE MedTech LLC
Jocelyn Jennings, MSRA,
RAC-Devices, RAC-Drugs,
RAC-US, RAC-Global,
FRAPS
Vice President, Regulatory Affairs
and Quality Assurance
Mycovia Pharmaceuticals, Inc.
Andrea Lopes, PhD
Clinical Manager
confinis ag
Colin Morgan, MS, CISSP,
CISM
Founder and CEO
Apraciti, LLC |Product Security
Hub, LLC
Allyson B. Mullen, JD
Director
Hyman, Phelps &McNamara PC
Dawn N. Norman, MS
Partner
MRC Global, LLC
Gretchen E. Parker, PhD, CIP,
RAC-US
Executive Advisor and Chair
Pearl Institutional Review Board
Foram Shukla, PharmD,
MS-RA
Regulatory Affairs Specialist
Medtronic
Flora Sandra Siami, MPH
CEO
S-Squared MedTech
Beat U. Steffen, MSc, MBA,
RAC-Devices, FRAPS
Founder &Principal Consultant
confinis ag
Charles Tam, MBA
Senior Director, Regulatory
Affairs
Edwards Lifesciences
Manuel Urena
Regulatory Strategy Director
Cochlear
Samata Veluvolu, MBA,
RAC-US
Principal Regulatory Specialist
Cochlear Americas
Melissa Walker, MS, RAC-US,
FRAPS
President
Graematter Inc
Anuja Yardi, MS-RA, MSPM,
MPharm, RAC-US
Regulatory Affairs Manager
Zimmer Biomet
Brian Young
VP, Global Regulatory Affairs
MiMedx