Laura Guy, MS, RAC, earned a BS in Psychobiology from UCLA and an MS in Regulatory Affairs from SDSU. Her Company, Regulatory Liaisons, LLC provides Regulatory Affairs and Quality System services to innovators and manufacturers of pharmaceutical (Rx and OTC), biologic, cosmetic, medical devices (including IVDs) and combination products. To support her clients, Ms. Guy establishes infrastructures that promote compliance with FDA/ISO/ICH/MDR regulations and standards. 

Kim Walker is an independent Global Regulatory, Quality, and Clinical Affairs Consultant and owner of Kim Walker Consulting since 2006 with over 30 years of industry experience.  She is active in non-profits, serving on the board of directors and various committees, and has managed, moderated, and presented at several professional conferences.  Kim has been an SDRAN Mentoring Committee volunteer since 2009 and RAC Study Group presenter since 2014.  She is a current instructor at SDSU and Roseman University and past instructor at UCI and CSUF for both graduate and undergraduate level regulatory courses.

Daniel Yeh, RAC, has over ten years of experience in the Development, Manufacturing, and Commercialization of medical devices. In his current role as the Director of Regulatory and Quality at MedWaves Inc., Daniel is managing new product submissions as well as maintaining international registrations. 

His regulatory work includes 510(k) submissions, managing the quality system, and responding to FDA and ISO audits. Outside of quality, he also oversees product development and manages clinical activities including distributor sales, product training and other medical affairs.

Azita Hedayati is a Regulatory professional with experience in quality assurance, regulatory affairs, and program management, having spent over two decades in leadership roles within the medical device and healthcare sectors.

Most recently, Azita served as the Sr. Quality Systems Program Manager at Medtronic, where she managed quality initiatives at the Northridge facility. Prior to that, she was the Sr. Director of Regulatory Affairs and Quality Assurance at eVent Medical, overseeing regulatory and quality compliance for medical products at the company’s Lake Forest office.

Olivia Yu, PhD, has extensive experience spanning exploratory drug discovery to clinical development and FDA approval. She has held various roles in preclinical research, Clinical Trial Management, Regulatory Affairs, and Project Management. She is currently a Project Manager at Navigate BioPharma Services Inc., a Novartis subsidiary. Olivia received her Doctorate in Biomedical Sciences from the University of California, San Diego and her Bachelor's Degree in Biochemistry/Molecular Biology from the University of California, Santa Barbara.

Jingrui (Jing) brings over 6 years of invaluable experience in the pharmaceutical and medical device industries, specializing as a design control/design quality engineer. With her expertise, she has successfully led numerous projects involving drug/device combination products, in vitro diagnostic devices (IVD), companion diagnostic products, and Software as a Medical Device (SaMD) products. Serving as a design control project lead, she has effectively provided both project management and technical leadership to ensure strict compliance with U.S. FDA medical device regulations (21 CFR 820) as well as international standards such as ISO 13485, ISO 14971, IEC 62304, 62366, EU MDR> and IVDR.