Jennifer Bolton
Senior Fellow, Regulatory Affairs, Boston Scientific
Jennifer has 30 years' experience leading key market and clinical regulatory approvals. She's developed and executed global strategies for combination products, left atrial appendage closure devices, integrations of acquired companies, mechanical circulatory support devices, transcatheter aortic valves, drug-eluting stents, abdominal and thoracic aortic stent grafts, peripheral balloons/guidewires, vascular surgery grafts/fabrics, and orthopedic implants. Jennifer has engaged in ISO standards committees, serves on the MDIC ENRICHMENT Industry Advisory Council, volunteers with a local Medtech Accelerator for early-stage startups, and is an Adjunct Instructor for the St. Cloud State University Regulatory Affairs and Services master's program.
Djuana Banks
Regulatory Affairs Manager, Medtronic
Djuana Banks is a Regulatory Affairs Manager at Medtronic in the Peripheral Vascular Health business, where she leverages her experience in global medical device submissions and regulatory strategy to support patient-focused innovation. She brings a strong background in both regulatory affairs and clinical research, leading complex projects and helping to shape market access strategies across multiple regions. Known as an agile, results-driven leader and relationship builder, Djuana partners closely with cross-functional teams to navigate evolving regulatory landscapes while mentoring and developing other regulatory professionals.
Lisa Pritchard, BSEEE, FRAPS
VP of Regulatory, Quality, Clinical & Engineering at DuVal & Associates, P.A.
Lisa Pritchard, BSEEE, FRAPS, is VP of Regulatory, Quality, Clinical & Engineering at DuVal & Associates, P.A., a law firm dedicated to counseling companies primarily in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. She focuses on advising clients on Regulatory, Quality and Compliance topics for medical devices including in vitro diagnostics, assisting clients with worldwide regulatory strategies, and FDA submissions such as pre-submissions, IDEs, 510(k)s, De Novos, and PMAs. Lisa currently serves as Chair of the Twin Cities Chapter for the Regulatory Affairs Professionals Society (RAPS). She is an active volunteer mentor and sought after international speaker on regulatory topics. Lisa brings over 35 years of experience in working with industry including start-up companies, multi-national corporations, and now consulting.
Georgiann Keyport
Senior Regulatory Advisor, Canopy Regulatory Solutions
Georgiann Keyport is a senior regulatory advisor at a consulting firm with over 40 years of global experience across the medical device, biotech, and pharmaceutical sectors. Her career encompasses regulatory affairs, quality systems, research and development, and clinical affairs management, with a primary focus on strategy and submission writing for Class II and III medical devices, drugs, biologics, and combination products. Georgiann is committed to education and has taught a master's level regulatory science course for 10 years. As she approaches the end of her professional career, she is dedicated to sharing her decades of “learned lessons” to motivate, mentor, and empower the next generation of regulatory professionals.
Jim Kleinedler
Director, Regulatory Strategy, Medtronic
Jim Kleinedler, Ph.D., is Director of Regulatory Strategy at Medtronic, supporting innovative programs across the product lifecycle. Previously at Boston Scientific, he led IDE, 510(k), and PMA submissions and engaged regulators on early feasibility, IRB/EC, and breakthrough designations in interventional cardiology. He also served as an FDA reviewer of Class II/III cardiovascular devices and biocompatibility focal point within CDRH. Dr. Kleinedler holds a B.S. in Chemical Engineering (Iowa State) and a Ph.D. in Toxicology (LSU). He has authored over a dozen peer-reviewed publications, holds seven patents, and teaches in St. Cloud State’s graduate regulatory affairs program.
Tabitha currently works as a Project Manager within Abbott’s Vascular business, focusing on new product development and regulatory strategy. With nearly nine years of experience in Regulatory Affairs, she has held roles with increasing levels of responsibility across both Abbott and Medtronic. She holds an MBA and a graduate certificate in Medical Device Development from the University of St. Thomas, building on a strong foundation in science and compliance. She is passionate about mentoring emerging regulatory professionals.
Steven Pavlik
Principal Regulatory Affairs Specialist, Boston Scientific
Steven Pavlik is a Principal Regulatory Affairs Specialist with more than 10 years of experience supporting global medical device submissions across Class II and Class III technologies. His expertise spans 510(k)s, Q-Subs, EU MDR, and international registrations. Steven is passionate about sharing early to mid career experiences. He believes in practical, honest guidance and creating pathways for others to grow in the field.
Kristen Evenson is a seasoned regulatory affairs professional with deep experience in FDA, EU MDR, UK, and global submissions across Class I–III medical devices, including software-driven and imaging technologies. She has led regulatory strategy, clinical evaluations, and complex submissions for startups, established manufacturers, and innovative imaging companies. Known for her strong project leadership and ability to navigate high-pressure, mission-critical environments, Kristen blends technical expertise with clear communication and collaborative problem-solving. She currently serves as Sr Manager of Regulatory Affairs at Hyperfine and Co-Chair of the Twin Cities RAPS chapter.
Numan Shaikh
Regulatory Affairs Specialist II, Boston Scientific
Numan’s career is focused on the dynamic and critical field of Medical Device Regulatory Affairs, a discipline he is deeply passionate about. He holds a Master’s degree in Regulatory Affairs and a Bachelor of Pharmacy, giving him a distinctive blend of expertise in product compliance and pharmaceutical science. He is truly inspired by the medical device industry and looks forward to sharing insights on what it takes to build a successful career in this evolving field.
CP (Chandrapaul) Parsram is a Senior Regulatory Affairs Specialist at Solventum, where he has advanced by combining strong technical writing skills with a passion for learning and commercializing products that improve healthcare globally. In his role, he partners across teams to develop and execute regulatory strategies for both new product launches and the ongoing success of existing products. Although CP is new to mentoring, he’s enthusiastic to hopefully provide others with the same guidance and support that made a difference early in his own career.
Sarah Osterbauer
Principal Regulatory Affairs, Software and AI, Boston Scientific
Sarah has worked in regulatory affairs with a focus on software and AI for about 12 years. She currently works at Boston Scientific, following four years at Philips and seven years at Medtronic. She is looking forward to mentoring someone who shares her passion for helping patients and contributing to exciting innovation in the medical device industry.
Marlene is currently a Regulatory Leader at Philips Healthcare (IGTD). She is passionate about bringing innovative medical devices to the market. Marlene has over 25 years of experience leading regulatory teams and developing global strategies. She is a member of the RAPS education committee and enjoys mentoring others.