Regulatory Services Staff

Vicki Anastasi, Director
Vicki oversees all activities of the regulatory services group, which provides strategic consulting and 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 device regulation. Prior to joining MDCI in 2007, Vicki served as director of regulatory affairs at TissueLink, Inc., where she was responsible for developing and implementing a U.S. and EU regulatory strategy for medical devices in the electro-surgery 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. She is an active member of AdvaMed and participates in many of the organization's industry working groups.

Mary McNamara-Cullinane, RAC, Senior Regulatory Consultant
Mary has over eighteen years of experience in regulatory and clinical affairs. She has varied expertise including the regulation of radiology, urology, physical medicine, orthopedic, wound care, and dental devices. Prior to joining MDCI in 1992, she was the clinical affairs coordinator at Davol, Inc., subsidiary of C.R. Bard, where her responsibilities included preparation of FDA submissions and management of clinical trials. Mary also was a product development scientist at Hygeia Sciences, where her responsibilities included management of consumer studies and development of over-the-counter diagnostic products. Mary holds a B.S. in biology from North Adams State College and is a member of the Regulatory Affairs Professionals Society. She is Regulatory Affairs Certified.

Cynthia J. M. Nolte, Ph.D., RAC, Senior Regulatory Consultant
Cindy has over ten years of experience in medical device regulatory affairs, with varied expertise including the regulation of infection control products, software-controlled instrumentation, implantable devices, and tissue engineered products. Prior to joining MDCI 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.

Gail E. Radcliffe, Ph.D., Affiliate Principal Regulatory Consultant
Dr. Radcliffe assists biotech, medical device and diagnostics companies with technical, marketing, regulatory and business development issues. Because she has expertise in each of these areas, she brings a unique product development viewpoint to manufacturers and is able to streamline overall business strategy. Dr. Radcliffe helps emerging companies identify potential applications for platform technologies through assessment of technical advantages and disadvantages and matching these qualities with customer needs. She provides regulatory strategy assistance, conducts technical due diligence, and monitors product development milestones. Dr. Radcliffe holds several patents and has worked with clients to obtain funding through angel investments, venture capital and Small Business Innovation Research (SBIR) grants.

Dr. Radcliffe obtained a Ph.D. in Molecular Biology from Brown University in 1986. She then completed a post-doctoral fellowship in molecular immunology at the University of Massachusetts Medical School. While at GENE-TRAK, in the early 90’s, she developed molecular diagnostic assays for several infectious disease organisms including HIV, CMV, MTB and Chlamydia. She was also responsible for instituting the clinical affairs group and has since helped usher several companies through the FDA process. Following GENE-TRAK, she joined Cytyc Corporation and worked in both technical and business development roles. Over the past 10 years, Dr. Radcliffe has provided consulting help to several diagnostic, medical device and pharmaceutical companies.

Dr. Radcliffe is on the board of the Massachusetts Biomedical Initiatives and Crescent Innovations. She is also a member of the executive board of the Worcester Polytechnic Institute Venture Forum and acts as an advisor to VC firms and to several venture backed biotech companies.

Jeffrey B. Roberts, Regulatory Consultant
Jeff has over twelve years experience in medical device regulatory affairs and quality management. He works closely with medical device manufacturers and suppliers to address FDA premarket requirements and ongoing quality assurance for a wide range of medical devices and systems.

Prior to joining MDCI Jeff was Regulatory Affairs Manager at Candela Corporation, where he was responsible for the development, negotiation, and implementation of U.S. FDA and international regulatory strategies for Candela's medical and aesthetic laser devices with indications for tattoo removal, hair removal and acne scar treatment. At Confluent Surgical, he managed FDA, EU and other international submissions for class II and class III absorbable implant medical devices with abdominal and neurosurgical indications. Jeff also served as a Project Quality Engineer at Mitek Products / Johnson & Johnson, a leading orthopedic product developer and manufacturer, where he was involved in surgical sports medicine and soft tissue repair devices.

Jeff holds his B.S. in Mechanical Engineering Technology from Wentworth Institute of Technology in Boston, MA. He is a member of the Regulatory Affairs Professionals Society and is a Regulatory Affairs Certification candidate.

Rosina Robinson, RN, M.Ed., RAC, Principal Consultant
Rosina has over thirty years of experience in regulatory affairs and healthcare delivery. She has authored over 50 successful 510(k)s and many PMAs and PMA supplements for products representing a variety of medical specialties, with particular expertise in the regulation of cardiovascular, minimally invasive and general surgical devices. She guides clients through all types of premarket regulatory and clinical trial activities, and is especially skilled at facilitating face-to-face communications between clients and the appropriate FDA center, including CDRH and CBER. Prior to joining MDCI in 1992, she was manager of clinical research and regulatory approvals at Haemonetics Corporation. Rosina is a member of the Regulatory Affairs Professionals Society, the Association of Operating Room Nurses, and the American Association of Blood Banks. She is a registered nurse, holds a M.Ed. from Bridgewater State College, and is Regulatory Affairs Certified. Rosina also served as an adjunct professor in the Northeastern University Master of Science in Regulatory Affairs program, from 2003 to 2007.

Mark W. Sheehan, Regulatory Associate
Mark began his regulatory affairs career in 2004 and has experience with a variety of therapeutic areas and medical specialties. He works closely with medical device clients to address FDA premarket requirements for a wide range of devices and systems. Prior to joining MDCI in 2008, Mark was a regulatory affairs associate at Integra Radionics where he was responsible for international and domestic regulatory submissions for neurosurgery devices and prepared Technical Files for medical imaging systems. At Lhasa OMS, Mark acted as U.S. Agent for electrotherapy device manufacturers and prepared 510(k) submissions for transcutaneous electrical nerve stimulation (TENS) devices. Mark holds two M.A.s in philosophy from San Diego State University and the University of California, Davis and a B.A. in philosophy from the University of Massachusetts, Amherst. He is a certified science educator and college lecturer.

Cynthia A. Sinclair, RAC, Principal Consultant
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 MDCI 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 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
Ron has over twenty-two years of regulatory and clinical affairs experience, with specific expertise in human-derived tissue engineered 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. Prior to joining MDCI in 2006, 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. Prior to that, he was with Sorin Biomedical, Inc., where 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.

Randy Veale, Strategic Regulatory Advisor
Randy has over thirty years of experience in the regulation of medical devices by the Food and Drug Administration. Until 2005, Randy oversaw all activities of MDCI's regulatory services group. Now, as a senior advisor, he is particularly skilled at working with clients to develop competitive regulatory strategies for novel and innovative medical devices. From 1973 to 1984, he served at the FDA, where he was involved in the implementation of the 1976 Medical Device Amendments and the creation of the agency's policies and regulations for medical devices. As a division director at CDRH, he was responsible for the scientific review and approval of hundreds of anesthesiology, neurology, and radiology medical device applications. Randy holds an M.S. in Electrical Engineering from the University of Wyoming.

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