Profile

Richard Vincins, RAC

Contact Details

Gold Member
RegEx Pro

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

  • US
  • Worldwide

Product Interests

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