Richard DeRisio

Richard J. DeRisio

Principal at The DeRisio Group , LLC

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The DeRisio Group , LLC

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Divisional Vice President, Regulatory Affairs - Abbott Medical Optics Inc

Vice President, Global Regulatory Affairs - Advanced Medical Optics , Inc.

Vice President, Quality Assurance and Reg Affs - KCI

Vice President, Medical Health Services, Americas Region - TÜV SÜD America Inc

Vice President, Global Quality Assurance and Regulatory Affairs - Covidien Ltd.

Divisional Vice President, Regulatory Affairs - Abbott Laboratories company

Similar Positions - Computer Motion , Inc.

Vice President, Global Regulatory Affairs - Kinetic Concepts , Inc.


bachelor's degree - chemical engineering , Cornell University

master's degree - food science & technology , Cornell University


Member - Regulatory Affairs Professionals Society

Member - American Institute of Chemical Engineers

Editorial Advisory Board - Medical Device & Diagnostic Industry

Member of the Regulatory Science Graduate Program Advisory Board - University of Southern California

Member of Board-Level Committees - MDMA

Member of Board-Level Committees - AdvaMed

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AFDO - 2013 Presentations

Richard DeRisio, Principal, The DeRisio Group, LLC

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Richard DeRisio
Richard DeRisio founded The DeRisio Group LLC to provide expert consulting support to FDA-regulated companies. In his prior industry roles, DeRisio had executive-level responsibility for global quality, regulatory, government affairs and compliance for major U.S. corporations including Abbott, Johnson & Johnson, Pfizer and Covidien, among others. In both operating divisions and corporate units, he has worked with a broad range of Class II and Class III medical devices including mechanical heart valves, ophthalmic implants and laser devices, implantable defibrillators, electrophysiology and neurovascular catheters, wound healing systems, robotic surgery devices, diagnostic products and sterilization equipment. During an earlier ten-year career in FDA's Washington offices, Mr. DeRisio worked in the Agency's field operations headquarters and later in the Office of Compliance in the Center for Devices and Radiological Health. Mr. DeRisio is a graduate of Cornell University, where he received a Bachelor of Science degree in chemical engineering and a Master of Science degree in food science and technology with a minor in microbiology. He is a member of the University of Southern California Regulatory Science Graduate Program Advisory Board. He serves on the Editorial Advisory Board for Medical Device & Diagnostic Industry magazine and on the Medical Design and Manufacturing Conference Advisory Board. He has been a member of AdvaMed and MDMA board-level committees, and is a member of AIChE and the Regulatory Affairs Professional Society. Mr. DeRisio holds the RAPS Regulatory Affairs Certification (RAC). Richard DeRisio

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Covidien - Investor Relations - News Release

Covidien Appoints Richard DeRisio Vice President, Global Quality Assurance and Regulatory Affairs
MANSFIELD, Mass. --(BUSINESS WIRE)--Mar. 19, 2012-- Covidien (NYSE: COV), a leading global provider of healthcare products, today announced the appointment of Richard DeRisio as Vice President, Global Quality Assurance and Regulatory Affairs, effective immediately. He will report directly to Mr. DeRisio will oversee all of the Company's activities related to Quality Assurance, Regulatory Affairs, Regulatory Compliance, Complaint Management and Design Quality Assurance. He also will establish and implement processes enabling continuous improvement and proficiency and will select and manage supporting technology platforms. Additionally, he will assist in designing and deploying strategies to facilitate global alignment of Covidien's Quality Assurance and Regulatory Affairs policies, procedures and best practices. A 40-year healthcare industry veteran, Mr. DeRisio has extensive, in-depth knowledge of quality and regulatory affairs. Most recently, he served as Divisional Vice President, Regulatory Affairs, for Abbott Medical Optics in Santa Ana, California , where he directed strategic analyses and regulatory processes for global product approvals, clearances, registrations and renewals. He earlier served in senior clinical, quality and regulatory management positions at several firms, including Mr. DeRisio has been actively involved in ANSI, the for Medical Device & Diagnostic Industry . Mr. DeRisio is a member of the Regulatory Affairs Professional Society and has earned Regulatory Affairs Certification. He holds a bachelor's degree in Chemical Engineering and a master's degree in Food Science & Technology, both from

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