Preparing to Take the RAC Devices Exam

Anjali Atal-Gupta, M.Ed, RAC is Associate Director, Regulatory Affairs at Novo Nordisk. In this role, she supports the development of global regulatory strategies for Novo Nordisk’s device delivery programs in its cell therapy R&D division. Previously, she worked at Stryker Corp. in its Neurovascular division managing US and EU Class III submissions and as a divisional process owner for EU MDR, as well contributing as an active member of International Organization for Standardization (ISO) and Advamed working groups. Prior to Stryker, she worked in both International and Domestic Regulatory Affairs at Boston Scientific on US Class III (neurovascular stent) and Class II products. Atal-Gupta started her medical device career in quality assurance at SMART Therapeutics. She has served in volunteer roles for RAPS for the past 15 years, including as speaker at RAPS’ annual Convergence and as a member of the Education, RAC Exam and Convergence Program committees. She has earned her Regulatory Affairs Certification (RAC US, EU and Device) and is also a Certified Quality Auditor (CQA).

Elizabeth Bereza, RAC is a regulatory affairs specialist at Microline Surgical Inc. She is involved in all areas of regulatory within the company, including premarket and postmarket activities, and quality system compliance. Bereza earned the RAC-Devices as well as Certified Medical Device Auditor status in 2019. She has a master’s degree in regulatory affairs from Northeastern University in Boston, and has worked in regulated industries for 18 years.

Leslie Cort, RAC, PMP is a Regulatory Business Process Program Manager for Global Regulatory Shared Services (GRSS) at Medtronic, where she leads functional and Enterprise-level programs and initiatives. Through-out her career, she has worked in Regulatory Affairs and supported a broad range of medical devices with experience in new product development, sustaining, international regulatory affairs and regulatory submissions.

Leslie’s educational background includes an undergraduate degree in Chemistry from Savannah State University, and a Master’s Degree from Northeastern University in Regulatory Affairs of Drugs, Biologics and Medical Devices. Leslie has served in volunteer roles at RAPS as a committee member for the RAC Devices Exam. In addition, she received the Regulatory Affairs Certifications, (US and Devices) from the Regulatory Affairs Professionals Society.

Stephanie Seidel, RAC is the Sr. Principal Clinical Evaluation Specialist at Medtronic. She has over 25 years of progressive and diverse experience in the medical device industry, including 20+ years of scientific and technical communication, and 16+ years in regulatory and clinical affairs. Expertise includes Class I, II/IIa/IIb, III devices, including multi-product systems. Active and passive implantable devices, software, wireless accessories, surgical tools and electromechanical hardware. Device expertise includes cochlear implant systems, peripheral vascular, neuromodulation and blood processing devices. Authored or collaborated on 125+ approved U.S. and international regulatory submissions in over 90 markets, including for Class III (high-risk) medical devices. Senior clinical evaluation strategist for the EU, China and other global markets.