Anson Employees Receive Regulatory Affairs Professionals Society (RAPS) Certification
(INDIANAPOLIS IN) December 21, 2009 - The Anson Group, a life science regulatory consulting business, is pleased to announce that two employees have passed the Regulatory Affairs Certification (RAC) exam. The RAC is awarded to individuals who perform well on a comprehensive examination that tests the knowledge of laws, regulations, policies and guidelines, with an emphasis on drugs, medical devices and biologics. The RAC designation is a mark of professional distinction identifying individuals committed to excellence, career advancement and pursuit of knowledge.
Mr. Russ Gray, RAC, a senior regulatory consultant for Anson, is now certified in U.S. regulatory affairs. . Mr. Gray has over 35 years of experience in the medical device industry. He has achieved his experience through a broad array of product development and technical management experiences in the design and development of numerous medical device, in-vitro diagnostic instrumentation, analytical instrumentation markets, and clinical laboratory and home data management products. His expertise includes product design control and risk management compliance systems. Currently, Mr. Gray focuses on executive management, leading product development and manufacturing organizations for companies ranging from major Fortune 100 corporations to start up companies in the medical device market.
Ms. Jamie Austin, RAC, is a regulatory associate at Anson and is now certified in both U.S. and Canadian regulatory affairs. Having earned her graduate degree in regulatory affairs at Johns Hopkins University and an undergraduate degree in chemical engineering from the University of Notre Dame, Jamie possesses a strong background in chemistry, biotechnology, and technical writing. Ms. Austin provides specific expertise in interpreting biocompatibility testing requirements and overseeing submission preparation. She works closely with clients in developing regulatory strategies to fit their marketing objectives. In addition to RAPS, Ms. Austin is a member of American Chemical Society and serves on the Alumni Advisory Board for the Minority Engineering Program at the University of Notre Dame.
About Anson Group
Headquartered in Carmel Indiana, Anson Group is a minority-owned independent consulting organization with over 14 years experience as a leading provider of services and strategies for FDA product approval and compliance for devices, drugs, biologics, and combination products. Anson Group’s team of experienced industry experts tailors both enterprise strategies and clearly-defined action plans that help its clients address crucial issues throughout the product life cycle. Anson works with clients in the United States, Europe, and Asia, from global pharmaceutical manufacturers to small pre-IPO or VC biotechnology and medical device start-ups.
