Medical Device Regulatory Senior Staff
Vicki Anastasi | Senior Vice President, Medical Devices
Vicki oversees all activities of the Medical Device Regulatory business unit, which provides strategic consulting, submission preparation and review to U.S. and international clients. She has over eighteen years of experience in the medical device industry, with over fifteen years specifically focused on medical device regulation.
Prior to joining Aptiv Solutions in 2007, Vicki served as director of regulatory affairs at TissueLink, Inc., (now Salient Surgical/Medtronic, Inc.) where she was responsible for developing and implementing a U.S. and EU regulatory strategy for medical devices in the electrosurgery market. At Vista Medical Technologies, Inc., an emerging device manufacturer, she served as regulatory affairs manager, responsible for regulatory activities supporting the company’s 3-D visualization and information systems to enable minimally invasive surgical solutions in cardiothoracic, head, neck and spine, general surgical and other microsurgical procedures. She is also experienced with in vitro diagnostic products, having held senior positions at ATC Diagnostics, Inc. and bioMerieux Vitek, Inc., where she was responsible for regulatory activities related to infectious disease and genetic-based products. Vicki holds a B.S. in medical technology from the University of Connecticut.
Frederick Tobia | Director of Regulatory and Clinical Services
Fred joined Aptiv Solutions in 2011 and oversees daily operations of medical device business unit. He brings over twenty years of experience in the medical device and CRO industry and has held senior executive roles in regulatory, quality and clinical affairs at Alliant Medical Technologies, Inc. (formerly UroMed), CareStat Inc., and Seacoast Technologies. He was vice president, regulatory and clinical affairs at NMT Medical Inc. He has successfully gained clearance and approval of PMAs, 510(k)s, IDEs, INDs, NDAs, BLAs, and international Design Dossiers with and without clinical data. Fred holds a bachelor of science in biology from Providence College and a certificate in public health from Harvard School of Public Health. He has published numerous articles in peer-reviewed journals and is a recognized speaker and advisor with medical device industry trade and professional organizations, including FDA task forces.
Cynthia A. Sinclair, RAC | Principal Consultant, Medical Device Regulatory
Cynthia has over thirty years of experience in the medical device field encompassing research and development, regulatory affairs, and quality assurance. She specializes in the regulation of in vitro diagnostic products, including the development of regulatory strategies, design of analytical and clinical study protocols, and the preparation of regulatory submissions. Prior to joining Aptiv Solutions in 1988, she was director of Quality Assurance and Regulatory Affairs at Ortho Diagnostic Systems, Inc., a Johnson & Johnson Company. She directed all regulatory affairs and compliance functions from product design and development through product introduction for in vitro diagnostic reagent and instrument systems. Cynthia is a member of the Regulatory Affairs Professionals Society, the American Association for Clinical Chemistry, and the Clinical and Laboratory Standards Institute. She holds a B.A. in Chemistry from Northeastern University and is Regulatory Affairs Certified.
Ronald S. Warren, RAC, CTBS (AATB) | Principal Consultant, Medical Device Regulatory
Ron has over twenty-five years of regulatory, quality and clinical affairs experience, with expertise in human-derived tissue engineered products, combination products and cardiovascular devices. He has coordinated and led multiple pre-IDE meetings and been involved in the submission and preparation of PMAs, 510(k)s, PMA Supplements, and IDEs for various clinical indications. He also has expertise in tissue establishment registration and Good Tissue Practice regulations. Ron joined Aptiv Solutions in 2006 and has assisted US and international firms in regulatory strategy development, pre-IDE submissions, IDEs and marketing applications for a variety of in vitro diagnostics and electronic medical systems.
Prior to joining Aptiv Solutions he served as executive director, regulatory affairs and quality assurance for Smith & Nephew Wound Management, and as head of regulatory affairs at Advanced Tissue Sciences, Inc. At Sorin Biomedical, Inc. he managed regulatory and clinical activities for the company’s complete line of cardiovascular and cardiopulmonary products including heart valves, catheters, oxygenators, and blood cardioplegia delivery systems. At Baxter Healthcare Corporation, Edwards Cardiovascular Surgery Division, Ron was responsible for clinical and regulatory activities supporting the company’s prosthetic heart valves and biological vascular grafts. He holds a B.S. in biology from the University of California, Irvine and an M.B.A. from California State University, Long Beach. He is a certified Tissue Bank Specialist and is Regulatory Affairs Certified.
Cynthia J. M. Nolte, Ph.D. | RAC, Principal Consultant, Medical Device Regulatory
Cindy has over fifteen years of experience in medical device regulatory affairs, with a focus on drug delivery systems – large volume infusion pumps for intravenous and parenteral routes of administration, diabetes management technologies including insulin delivery devices, glucose monitoring technologies, and stand-alone software products for blood glucose control. She supports manufacturers of these systems in assurance case preparation, non-clinical test design and the development of usability assessment programs that meet current FDA expectations. She has authored 510(k) premarket notifications for a range of complex medical device products and systems including drug delivery systems, stand-alone software products, software-controlled instrumentation, implantable devices, infection control products and tissue engineered products. Prior to joining the company in 1995, she was a staff scientist at Organogenesis, Inc., where she was involved in the design and development of cellular tissue substitutes. Cindy is a member of the Regulatory Affairs Professionals Society, the Association for the Advancement of Medical Instrumentation, and the North Carolina Regulatory Affairs Forum. She holds a B.A. in biology from Wheaton College and a Ph.D. in biochemistry from Boston University. She is Regulatory Affairs Certified.
Brian Edwards | Senior Regulatory Staff Consultant
Brian joined Aptiv Solutions in 2011 and is based in Minneapolis Minnesota. He brings over 20 years of experience in the medical device industry, with expertise in the design and analysis of clinical trials, biostatistics, development of global regulatory strategies and submissions, quality systems, and interactions with regulatory bodies. His specific medical device experience includes work with spinal orthopedic implants and instrumentation, active implantable middle ear devices, interventional cardiology devices, electrotherapy devices, cardiac rhythm management devices, and related accessories. Prior to joining Aptiv Solutions, he served as Director of Regulatory Affairs at Zimmer Spine and also held senior regulatory and quality positions at Otologics, Compex and Medtronic with experience managing global regulatory market approvals for Class II and III products in the United States, European Union, Canada, Latin America and Asia. Brian holds a B.S. in Chemical Engineering, a M.S. in Biomedical Engineering from the University of Minnesota, and a M.S. in Biostatistics from the University of California, Los Angeles. He is a member of the Regulatory Affairs Professionals Society (RAPS).
Susan M. Rockwell, M. Ed. | Corporate Brand Manager, Medical Devices
In her role as Corporate Brand Manager, Susan works closely with clients and the internal Aptiv Solutions medical device experts to support strengthen and broaden our medical device service offerings.
Susan has over twenty-five years of experience in clinical and healthcare research, with particular expertise in managing clinical trials for orthopedic, urological, and cardiovascular devices. Prior to joining Aptiv Solutions in 1988, she coordinated cardiovascular drug trials at Boston University Medical Center and managed healthcare programs at the American Heart Association, Massachusetts Affiliate. Susan is an active member of the Association of Clinical Research Professionals, where she has served on the Board of Trustees and as Chair of the Editorial Advisory Board. She is also past chair of the ACRP Device Forum. She holds a M.Ed. in Health Education from Boston University and a B.A. in Biology from the University of Virginia.