iv Regulatory Affairs Professionals Society (RAPS)
Author
Acknowledgments
Editors
Jocelyn Jennings, MS, RAC-US, RAC-
Drugs, RAC-Devices, FRAPS
Vice President, Regulatory Affairs and
Quality Assurance
Mycovia Pharmaceuticals, Inc.
Jay Y. Vaishnav, PhD, RAC-Devices,
FRAPS
Director of Regulatory Affairs
Canon Medical Informatics, Inc.
Section Editors
Pat Baird, MBA, MS
Senior Regulatory Specialist
Philips
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
Kiran Gulati, MBA
Principal Medical Device Consultant
Kiran Gulati &Associates
Darin S. Oppenheimer, DRSc, MS,
RAC-US, RAC-Global, RAC-Devices,
RAC-Drugs, PMP, FRAPS
Vice President Regulatory Affairs
BD
Joseph Tartal
Deputy Director, Division of Industry and
Consumer Education
Food and Drug Administration
Richard A. Vincins, RAC-Devices
Principal Strategy Consultant
NAMSA
Authors
Andrea K. Agree, PhD, RAC-Devices,
RCC-IVDR, RCC-MDR
Senior Regulatory Scientist
MED Institute
Khyati Jagdish Ashtekar, MS
Senior Regulatory Affairs Specialist
Medtronic
Sainath Babu, PhD, DABT, ERT
Regulatory Scientist, Toxicology
MED Institute
Meaghan Bailey
Principal Consultant
Evera Regulatory Advisors, LLC
Armin Beck, MBA, MS
CEO
Suntrix Consulting LLC
Sai Prathyusha Bhamidipati, MS, RAC-US
Director, Global Regulatory Science CMC
Moderna
Medha Sateesh Bharadwaj, MS
Senior Regulatory Affairs Specialist
Intuitive
Jorn van Binsbergen, MS
Consultant
Qserve Group
Prithul Bom, MBA, MS, RAC-EU, RAC-
US
CEO
FDA Accredited Third Party Review
Organization RTS
Gert Bos, PhD, FRAPS
CSO
Qserve Group
Ricki A. Chase, MS
President
RChase Consulting LLC
Helen Hwang Chow, PhD, RAC-US
Mayo Clinic
Richie Christian, MSc, RAC-Devices
Medical Device Consultant
wega Informatik AG
Rowena Cook, MS, RAC-Global, RCC-
IVDR
Senior Regulatory Affairs Specialist
Twist Bioscience
Holly Cotter, RAC-Devices
Senior Consultant
RQM+
Jay Crowley, MS
Vice President, Medical Devices
USDM Life Sciences
Philip Desjardins, JD
Partner
Arnold &Porter LLP