Join us for Future Leaders in Quality & Regulatory: SoCal Student Networking Event, an in-person opportunity to explore career paths, hear from industry professionals, and connect with a supportive Q&R community in Southern California.
This event will feature 4 experienced and local speakers representing three collaborating organizations, sharing real-world insights into Quality and Regulatory careers in the medical device industry, followed by networking with professionals in the field.
🤝 Organized in collaboration with:
- RAPS SoCal Local Networking Group
- Orange County Regulatory Affairs – Discussion Group
- ASQ Medical Device Division
Whether you’re exploring career options or preparing for your next step, this event is a great way to learn, ask questions, and build connections.
Registration Fees & Deadlines
Free
Speakers
Jay Vaishnav is a senior regulatory leader specializing in software and medical imaging, with 20+ years of experience spanning the FDA, NIST, industry, startups, and academia. She leads regulatory strategy and submissions for Canon Medical’s advanced imaging and AI-enabled software portfolio, including CT, MR, and radiology workflow applications.
RAPS has been a defining force throughout Jay’s career, beginning with her transition from basic research into regulatory work during her years at the FDA, where she first learned the discipline through the RAPS Fundamentals series. The RAC Devices credential later enabled her transition from industry medical affairs back into regulatory affairs, accelerating her path into leadership roles. She has since served on the RAPS Editorial Advisory Committee and the RAC (Devices) Exam Committee, is the Orange County Regional Lead for the SoCal LNG, and is a RAPS Fellow and elected Vice-Chair of the Fellows Committee. Jay is also co-editor of two RAPS-published books, Fundamentals of Medical Device Regulations: A Global Perspective and From X-Rays to AI: Navigating U.S. Regulation of Radiological Health.
Her long involvement with RAPS has shaped her leadership, strengthened her community-building work, and deepened her commitment to mentoring the next generation of regulatory professionals. Jay teaches regulatory strategy at UC Santa Cruz Silicon Valley Extension and speaks widely on AI-enabled SaMD, imaging informatics, and global convergence in medical device regulation.
Nancy Singer specializes in the professional development of students and professionals in regulated industries. She is an adjunct associate professor at the USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences. She has taught extensively for the FDA Staff Colleges and the FDA Program District Offices. Previously, she served as Special Counsel for the Advanced Medical Technology Association and began her career in the Department of Justice Honors Program, litigating FDA enforcement cases. She later became a partner at Kleinfeld Kaplan and Becker. Her contributions to improving communication between government and industry have been recognized with the Vice President’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. Nancy holds a BS degree from Cornell University and JD and LLM degrees from New York University Law School. She is a retired commander after serving 21 years in the Naval Reserve.
Shep Bentley, RAC
Principal Consultant, Benley Biomedical Consulting LLC
“Shep” has 42 years of experience working in the medical industry, starting in 1984 as a research technician at Hospital Corporation of America. Subsequently, he has managed Kendall-McGaw Laboratories, Inc. parenteral and non-ethical drug production, TOSHIBA America Medical System’s crashcart/T1600 manufacturing, and in 1993 founded Rising Star, Inc. to produce a variety of assemblies for the biomedical industry. He sold this venture to Standard Industries in 1997, and by 2004, he set up a full service biomedical regulatory consultancy, Synergy Biomedical, LLC and concurrently Supercomal Medical Products (M) Sdn Bhd, a Malaysia-based CDMO. When Synergy Corp was acquired by ICF International in 2005, he spun off as Bentley Biomedical Consulting, LLC in 2006.
Since the establishment of his independent biomedical regulatory consultancy, Shep has worked closely with large companies (Fortune 500) and small ventures around the world to facilitate their interaction with the FDA, drafting submissions that apply various novel approaches to the portrayal of drug and device risks to patients, and clinicians. These submissions have produced competitive results for the companies, and he has served in the CEO role on multiple occasions. He speaks at symposia, conferences, and various biomedical/biotech events around the world (Europe and Asia) and has published articles and book chapters on regulatory affairs. He is retained by various laboratories (Eurofins, NAMSA, Intertek, etc.) for compliance.
Shep is an active member of the Orange County Regulatory Affairs (OCRA) Discussion Group, Regulatory Affairs Professional Society (RAPS), the Association for the Advancement of Medical Instrumentation (AAMI), the American Society for Quality (ASQ), and is a Member of The Organisation for Professional Regulatory Affairs (MTOPRA). He has actively maintained the Regulatory Affairs Certification (RAC) for U.S. medical regulation for the past 20 years.
Tiffany Abrams
Sr. Director, Supplier Quality West Region, Medtronic
Tiffany Abrams is a Senior Supplier Quality leader with over 20 years of experience in the medical device, pharmaceutical, and biotech industries. She has held quality leadership roles at major organizations including Edwards Lifesciences and Abbott, with expertise spanning supplier quality, post-market surveillance, auditing, and CAPA. Tiffany is also an active ASQ leader and instructor, supporting the professional development of quality professionals across Southern California.
Location
UCI Campus
510 E. Peltason Dr.
Irvine, CA 92697
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
support@raps.org.