Richard provides leadership for the PAREXEL Consulting practice. Interfaces with the highest level of management at clients of PAREXEL, providing both direct consulting and assistance to clients. 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 20 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. A recognized expert in FDA design control requirements for medical devices. Richard serves as the expert consultant to medical device companies who have been enjoined by the FDA and are required to retain 3rd party representation to certify compliance. Assist clients with FDA pre-approval inspection readiness and remediation activities. Provides strategic compliance advice and develops effective communication strategies in response to FDA 483 observations, warning letters, and other FDA enforcement sanctions. Works with medical device developers at all stages of the product development lifecycle to ensure full compliance with QSR and successful commercialization of the product.Prior to joining PAREXEL, Richard held several positions with the FDA, including Field Investigator, Engineer and Manager of Medical Device Team. Core Specialities:• Medical Device Quality Systems Regulations (QSR)/Quality Systems Inspection Technique (QSIT), Complaint Handling System and Medical Device Reporting (MDR) Compliance• Design Controls for medical devices, including combination products• Device Pre-approval Inspection (PAI) requirements• Drug GMPs/Quality Systems requirements• Management of regulatory situations involving FDA, i.e. 483s • GAP analysis and Corrective Action Plans
Listed skills include Fda, Pharmaceutical Industry, Medical Devices, Regulatory Affairs, and 10 others.
