Profile

Richard Vincins, RAC

Contact Details

United States

Bio

Medical Devices: * Diagnostic short term and long term monitoring devices * Disposable and re-usable devices * DNA based diagnostic tests * ELISA based diagnostic tests * EO and Gamma sterilized medical devices * Gastroenterology devices * Implantable long term catheters * Implantable bone structure devices * IVD devices * Medical lasers for surgery applications * Optical medical devices * Software controlled devices and applications * Surgical devices QA & RA * FDA Quality System Regulation (QSR) - 21 CFR 820 * ISO 13485:2016 and ISO 9001:2015 * Canadian Medical Device Regulations (CMDR) * Internal auditing for compliance and improvement * Risk Management ISO 14971 * Corrective Action and Preventive Action (CAPA) systems * Process validation and design controls * Training of quality system applications and standards * Statistical techniques and analysis tools * 510(k) applications for medical devices * Technical Documentation

Education

Bridgewater State College
Bachelor of Science
1999 To 2001

Borah
High School Diploma
1986 To 1989

Job History

Vice President Regulatory Affairs
Union, NJ, United States
January 2017 - present

VP Quality Assurance
December 2007 - January 2017

Quality Manager
January 2000 - January 2001

Quality Assurance and Regulatory Affairs Manager
January 1992 - January 1998

Quality Assurance Specialist
January 1990 - January 1994

Regional Areas of Interest

  • Europe
  • Latin America & Caribbean
  • North America

Highest Level of Education Completed

  • Baccalaureate/Bachelors/first university degree