Profile

Richard Vincins, RAC

Contact Details

Bio

Medical Devices: * Bench top diagnostic analyzers * 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 14971:2007 * 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 File and Dossiers for medical device and IVD submissions * Labeling and Instructions For Use review * Clinical trial protocol development, planning, monitoring and auditing

Education

Bridgewater State College
Bachelor of Science
1999 To 2001

Borah
High School Diploma
1986 To 1989

Year Entered Profession

  • 1985-1989

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

Highest Degree Earned

  • Baccalaureate

Regional Interests

  • Europe
  • US
  • Worldwide

Product Interests

  • Biologics
  • Biomaterials
  • Biotechnology
  • Combination Products
  • Innovative Pharmaceuticals
  • IVDs
  • Medical Devices