Richard E. Wright

Richard E. Wright

Richard E. Wright

Vice President, Technical

Richard manages a team of Parexel consultants and serves as a member of the management team responsible for the Strategic Compliance organization. He advises FDA-regulated companies worldwide on the FDA Quality System Regulation (QSR) and strategies to help medical device and pharmaceutical companies achieve both FDA compliance and business objectives. Richard draws on 22 years of experience working with the FDA and over 18 years of strategic compliance consulting across a broad range of Class I, II and III medical devices, including radiology, cardiovascular, in vitro diagnostics, and drug/device combination products. Richard has expertise in FDA design control requirements for medical devices including combination products.

Richard serves as expert consultant to medical device companies who have been enjoined by the FDA and are required to retain 3rd party representation to certify compliance, which the FDA subsequently concurred. He utilizes his experience to assist clients with FDA pre-approval inspection readiness and remediation activities that have resulted in FDA approvals. He provides strategic compliance advice and develops effective communication strategies in response to FDA 483 observations, warning letters, and other FDA enforcement sanctions. Richard works with developers of medical devices at all stages of the product development lifecycle to ensure full compliance with QSR and successful commercialization of the product.

Work Experience

Prior to joining Parexel, Richard held several positions with the FDA, including Field Investigator and Manager of Medical Device Team. He worked with the Center for Devices and Radiological Health (CDRH) to develop new regulations, policies and procedures, including Design Control Requirements for medical devices and Quality System Inspection Technique (QSIT) for conducting medical device inspection. 

Education

Richard holds a B.S. in Electrical Engineering from Northeastern University, Boston, MA. He is a member of AAMI, ASQ and RAPS. He has served as a committee member and lead presenter for AAMI and RAPS. In 1998, Richard was awarded FDA’s Commendable Service Award for superior performance in educating the New England District medical device manufacturing community on the requirements of the FDA quality system regulations.

We are always available for a conversation.

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