Southern California LNG In Person Event: Launching Your Career in Medical Product Regulatory Affairs

Nancy Singer, JD, LLM, RAC, FRAPS

President, Compliance-Alliance LLC

Nancy Singer is president of Compliance-Alliance LLC. She is on the faculty of George Washington University School of Medicine and Health Sciences and teaches classes for FDA Staff Colleges and FDA District Offices. Previously, she served as special counsel for the Advanced Medical Technology Association. For her efforts to improve communication between the government and the regulated industry, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA commissioner’s Special Citation. She began her career as an attorney with the United States Department of Justice doing litigation for FDA enforcement cases. Subsequently she was a partner at the law firm of Kleinfeld, Kaplan and Becker. Nancy is a retired commander in the Navy Reserve.

: https://www.linkedin.com/in/nancysingerjd/

Jay Vaishnav

Director of RA, Canon Medical Informatics, Inc.

No bio provided

: jyvaishnav

Julie Manchester

VP, Regulatory Affairs & Quality, Autonomix Medical

No bio provided

: juliemanchester

James Wabby BSc., MHMS

Head, Global Regulatory Affairs - Emerging Tech and Combination Products, AbbVie

James Wabby has 23 years of experience in increasing regulatory compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to medical devices, medicinal delivery platforms, companion diagnostics, digital medicine, and combination product areas. He regularly provides AbbVie therapeutic franchise units with regulatory counsel and strategy to all aspects within the quality management system and regulatory affairs. James is an internationally recognized leader as he is a member of various regulatory/quality work groups and is a speaker and keynote at various regulatory symposia. In addition, he is the chair of the RAPS -LNG Southern California, vice chair RAPS RCC Committee, chair of the DIA Combination Products Committee, chair of the ISPE Combination Products (CoP), and a moderator for various global regulatory panel discussions.

: james-wabby-mtopra-2960296

Coco Oxford

COO, PRN Medical

Corina “Coco” Oxford serves as Chief Operating Officer of PRN, where she supports regulatory and operational strategy for medical device companies navigating global market requirements. She works with emerging and established companies to streamline regulatory processes and support successful product development and commercialization. Coco also serves as a Board Member of the Orange County Regulatory Affairs Discussion Group (OCRA-DG), supporting professional development within the regulatory affairs community.

: corinaoxford

Rena Pandit

Executive Director, Head of Safety Business Excellence, Amgen

No bio provided

: rena-pandit-3a60b735

Dongmei Huang

Director of Clinical Process Compliance, AbbVie

Dongmei Huang is a Clinical Compliance Leader with a proven record of leading the design, implementation, and optimization of global Clinical Quality Management Systems and Quality Management Systems across pharmaceutical, biopharmaceutical, biotechnology, and medical device industries.  She is Director of Clinical Process Compliance at AbbVie, as well as President of the SABPA OC/LA chapter.

Shep Bentley RAC

Principal Consultant, Benley Biomedical Consulting LLC

Shep Bentley is the President and Principal Consultant for Bentley Biomedical Consulting, LLC, where he is responsible for regulatory strategies leading to FDA approvals and clearances for digital medical device companies.

Shep began his career in 1984 at the Hospital Corporation of America as a research technician, and worked at McGaw Labs in Irvine, responsible for GMPs until 1989, when he joined TOSHIBA America where he managed production of various digital devices. He founded Rising Star, a contract manufacturer for digital medical assemblies in 1993, and sold it in 1997 to Standard Industries in Anaheim. He was a founder of Volcano Therapeutics, Inc. in 2001, which was acquired by Philips in 2015.

For the past fourteen years since 2004 as an independent consultant, Shep has worked to achieve device approvals and clearances from the FDA, and market entry for numerous innovative medical technologies and applications within the European Union, Canada, Brazil and across Asia.

He speaks regularly at regulatory conferences, has just co-authored a book on device approval and provides independent consulting for clients of Intertek. He is a graduate of The University of The South, and has studied international literature at the Johannes Gutenberg University in Mainz, Germany.

He is a member of AAMI, ASQ, RAPS, TOPRA and is the Director of Educational Programs for the Orange County Regulatory Affairs (OCRA) Discussion Group.

: shep-bentley-29939a2

Nora Emerson

Ph.D. Candidate in Neurobiology, UCI

No bio provided

: nora-emerson