Our staff of former FDA and EU officials as well as Industry experts allows us to combine global regulatory knowledge with industry best practices to help our clients achieve a compliant quality system that is right for their business. Our team has extensive experience in the development, marketing, and international regulation of medical device products, and a proven record of achieving client success.
Elaine Messa, RAC, FRAPS - President, Health Sciences Medical Devices
Elaine Messa has over 30 years of experience in FDA regulation of medical devices, focused on the development and implementation of compliant quality systems for medical devices in the United States and abroad. Her most recent position at FDA was Director of the Los Angeles District. Ms. Messa has significant experience in auditing, agency communication, development of quality systems, and design and implementation of corrective action plans to address complex compliance situations including consent decrees, Corporate Integrity Agreements, warning letters and 483s. Ms. Messa was previously the Executive Vice President of Becker & Associates Consulting, where she oversaw the quality systems and compliance consulting services for Becker Consulting’s medical devices practice.
Kim Trautman, Executive Vice President, Medical Device International Regulatory Compliance
Kim Trautman has over 30 years of experience in medical device quality systems and international regulatory affairs. She is focused on expanding international regulatory affairs and compliance services for NSF’s medical device clients, including expanding medical device training services worldwide and spearheading the development of an independent, third-party regulatory certification program. Ms. Trautman previously worked for the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) where she led the CDRH’s international efforts and initiatives. She was responsible for writing the current U.S. FDA Medical Device Quality System regulation and preamble published in 1996. She also developed and implemented the extensive quality system regulation roll out and training programs, and led continuing harmonization efforts with ISO 13485.
Tom Dzierozynski - Executive Vice President, NSF Avarent
Tom Dzierozynski has over 20 years’ experience in the pharmaceutical, medical device and biologics industries. Through comprehensive and practical knowledge of operations, regulatory affairs and quality systems, he has developed and implemented risk-based strategies that integrate varying business functions to drive ownership and improve operational and quality performance. He’s led technically-oriented projects focusing on design controls, verification and validation, process improvement, regulatory market clearance, risk management and implementation of corrective actions to address/avert enforcement actions. Earlier in his career, Mr. Dzierozynski was Vice President of Validation Services for Quintiles Consulting, and held quality, engineering and management positions at Baxter Healthcare Corporation.
Ian Fleming - Executive Vice President, NSF Avarent
Ian Fleming has over 18 years’ experience in FDA-regulated industries delivering system and process improvements for medical device and pharmaceutical companies. His experience includes auditing and risk analysis from a compliance and operational perspective as well as assessment, remediation and implementation of quality systems. He has led software/computer system development, remediation and validation efforts, and 21 CFR Part 11 compliance efforts for ERP/MES systems, relational and object oriented databases, SCADA and process control systems, medical device software, clinical data systems, sample accountability systems, in vitro diagnostics and laboratory data management. He held various roles at Packard BioScience, most recently as Senior Product Specialist, and was a Microbiology Technologist at North American Science Associates.
James Pink – Vice President, Europe, NSF Health Sciences Medical Devices
James Pink has 17 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body. His industry experience includes managing development and quality assurance programs for orthopedic, cardiovascular, wound and combination products. Mr. Pink has a team of experts based in Europe who have over 20 years’ individual experience in both competent authority and notified body leadership. He has coordinated and presented to EU competent authorities and expert working groups relating to classification decisions, clinical study design, scientific and technical briefings, and EU remediation strategies.
Mary C. Getz, Ph.D. - Vice President, Quality Systems & Compliance
Mary Getz has over 25 years of industry experience, including extensive expertise in developing quality, compliance and regulatory affairs strategies and solutions. She has helped domestic and international manufacturers to develop and implement comprehensive compliance action plans. The results were effective quality systems which lead to successful FDA and notified body inspections as well as NDA and PMA product approvals. Dr. Getz has hands-on experience with IVDs, 510(k) and PMA medical devices, as well as OTC and NDA pharmaceuticals. She has held vice president-level roles in quality and regulatory affairs at numerous multinational companies in the healthcare sector. Dr. Getz was previously the Director of Quality Systems and Compliance at Becker & Associates Consulting.
Meaghan Bailey, RAC - Senior Director
Meaghan Bailey’s expertise is in the analysis of complex regulatory challenges, and her consulting supports the development and compliant marketing of innovative medical devices. She advises life science companies on regulatory strategies, prepares regulatory submissions, conducts literature reviews and other analyses, and provides assistance with preclinical and clinical programs. Ms. Bailey has particular expertise in preparing sponsors for Medical Devices Advisory Committee panel meetings, and in supporting other premarket FDA interactions on behalf of a sponsor. Ms. Bailey has supported the development and commercialization of a wide variety of products including in vitro diagnostics, devices for the treatment of women’s health issues and diabetes management devices. Ms. Bailey was previously a Managing Director for Innovative Healthcare Products at Becker & Associates Consulting.
Kristen Grumet - Executive Director, Quality Systems
Kristen Grumet has over 25 years of experience including nine years at FDA as a Field Investigator specializing in the area of medical devices, and 16 years working and consulting for medical device companies in quality systems compliance. At FDA, Ms. Grumet served on the Design Control Inspection Strategy (DCIS) and Pacific Region Design Control Training Cadre teams to develop, implement and train industry on the use of the DCIS questionnaire in FDA medical device inspections. She was a Phase II certified performance auditor and a member of the first FDA cadre of certified medical device investigators. She conducted numerous medical device inspections in Europe with the FDA foreign inspection cadre, and has managed successful third-party certifications for companies under FDA consent decree.
Ronald M. Johnson - Expert Consultant
Ron Johnson has more than 30 years of senior FDA leadership experience as well as 14 years of applied consulting practice assisting FDA-regulated companies with complex regulatory and compliance matters, particularly in the field of medical device compliance and quality systems. Through numerous senior FDA management positions at the district office level and at the Center for Devices and Radiological Health (CDRH), and experience as a trusted advisor to industry, both as a consultant and a valued board member for pharmaceutical corporations, Mr. Johnson has developed a uniquely multi-faceted perspective on regulatory and compliance issues.
Mr. Johnson’s wide ranging experience and resulting intimate understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry enable him to develop and execute strategic, timely solutions for industry that both meet current client needs and anticipate potential future issues. Mr. Johnson previously served as President of Becker & Associates Consulting.
Kurt L. Moyer, Ph.D. - General Manager, NSF Health Sciences
Kurt L. Moyer has more than 23 years of pharmaceutical development experience spanning all areas from discovery support to marketed products. His primary expertise is in the areas of bioanalysis, extractables and leachables, method development and validation, identification of impurities and metabolites, and GLP/GMP compliance. He also has extensive experience with drugs for anticoagulant and cardiovascular therapies. In addition, Dr. Moyer provides NSF Health Sciences clients with project management that is designed to accelerate the development process. Prior to joining NSF Health Sciences, Dr. Moyer served as a Senior Research Investigator for Sanofi Aventis and a Research Scientist for the DuPont Pharmaceutical Company. Dr. Moyer received his Ph.D. in biochemistry from Villanova University.
Harold “Wally” Pellerite - Expert Consultant
Wally Pellerite helps guide the development of NSF’s medical device compliance practice in addition to providing technical consulting solutions for clients. He is the former Director of Strategic Compliance at Quintiles Consulting in Maryland, where he applied his significant experience with regulatory requirements for medical devices and experience in evaluating and resolving compliance and enforcement issues. From his 30 year career within FDA’s Center for Devices and Radiological Health (CDRH), Mr. Pellerite has an extensive historical knowledge of FDA enforcement strategies, policies, and actions. He works with clients to develop and execute cost-effective gap analyses and corrective action plans in response to FDA 483s, Warning Letters, and other regulatory actions. He is recognized as an expert in the Medical Device area and has served as an expert witness in numerous civil cases.
Timothy Ulatowski - Expert Consultant
Timothy Ulatowski has over 36 years of public health experience, including more than 20 years in multiple leadership positions at FDA’s Center for Devices and Radiological Health (CDRH). He most recently served as Director of the Office of Compliance at CDRH, where he managed and supervised four divisions responsible for ensuring compliance with medical device regulations. Mr. Ulatowski has proven expertise in advising industry on regulatory issues, assessing compliance and enforcement actions, evaluating premarket documents, and resolving complex technical and scientific problems.
Maria I. Vizcaino, Ph.D., Group Leader, Extractables & Leachables, NSF Health Sciences
Maria I. Vizcaino has over 10 years of experience in metabolite identification and structural analysis with a focus on mass spectral metabolomics, as well as method development and optimization. Her most recent training was at Yale University, where she designed and implemented a high-resolution mass spectrometry metabolomics workflow for the characterization of unknown small molecules with potential human health impact. Dr. Vizcaino’s areas of expertise include identification and analysis of active compounds, metabolite identification and structural analysis, method development and optimization, nuclear magnetic resonance characterization and microbiology. She holds a Ph.D. in natural product chemistry/microbiology from the Medical University of South Carolina and completed post-doctorate training in the Chemistry Department at Yale University.
Richard C. Wedlich, M.S. - Director of Quality Assurance, NSF Heath Sciences
Richard C. Wedlich has more than 30 years of R&D experience in the pharmaceutical, chemical and aerospace industries. Prior to joining NSF Health Sciences, Mr. Wedlich was Principal and Co-Founder of Pharmalytica Services, LLC, where he served as Vice President and Executive Director of Quality Assurance and Regulatory Affairs for over 10 years. He has also held the positions of Senior Engineer at the Schering-Plough Research Institute, Senior Process Safety Specialist at Chilworth Technologies, Senior Research Chemist at Olin Corporation, Scientist at Lockheed Engineering, Management and Sciences Company (NASA WSTF) and Chemist at Organon Pharmaceuticals. Mr. Wedlich has published numerous peer-reviewed, scientific articles. He holds a Bachelor of Science degree in chemistry from Ramapo College of New Jersey and a Master of Science degree in chemistry from Marquette University.
Steve Yost - Principal Consultant
Steve Yost has over 13 years of experience in FDA regulated industry, primarily in medical device manufacturing. He has served as an FDA Consumer Safety Officer in the Office of Regulatory Affairs, receiving numerous awards for outstanding performance, including a nomination for the Patrick J. Poulzer National Investigator of the Year Award. His efforts since leaving FDA have focused on the development and implementation of quality systems for the medical device industry in the US and abroad, as well as the creation and submission of 510(k)s and PMAs. He has also held various management positions in quality and regulatory departments at medical device, IVD, and human cellular and tissue product manufacturers. Steve’s areas of expertise include auditing, audit preparation such as mock FDA audits, quality system remediation, regulatory submissions and the development of responses to warning letters and FDA 483s.
- 3 months ago
FDA Regulatory and Compliance News FDA’s Center for Devices and Radiological Health (CDRH) announced the availability of a guidance for...
- 3 months ago
FDA Regulatory and Compliance News FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) supported, by a vote of 14...
- 5 months ago
ANN ARBOR, Mich. – NSF International, a leading provider of regulatory compliance, quality systems, analytical testing, education and consulting services...