Richard Vincins - Senior Consultant, Quality Assurance & Regulatory

Richard brings a wealth of FDA and European regulatory expertise to Emergo, experience gained from 17 years of working in quality assurance and regulatory affairs with a variety of medical device companies including Medtronic, Bard, and HemaCare. Richard is well-versed in the requirements of the Medical Device Directive (MDD), In Vitro Diagnostics Directive (IVDD), and other directives for CE Marking in the European community.

In addition to his vast knowledge of quality systems regulations, Richard also has experience with clinical trial management, site qualification, monitoring, and regulatory file completion. He has completed numerous CE Technical Files for IVD devices and is a certified Lead Auditor. Risk Management is also an area of expertise.

EXPERIENCE:

Director, Regulatory Affairs and Quality Assurance, HemaCare BioScience (2005-2007)

• Implemented procedures to support the manufacturing of IVD samples and clinical trial management.
• Create systems for the management of customer regulatory files for clinical trial data management.
• Responsible for the management and compliance of the Quality Management System.
• Support clinical trial functions in site qualification, site monitoring, and regulatory file completion.

Director, Quality Assurance and Regulatory Affairs, StatSpin, Inc./Iris Diagnostics (2002-2004)

• Achieved ISO 9001:2000 and ISO 13485:2003 certification with one minor observation.
• Executive team member for successful launch of $30 million product line with world-wide distribution.
• Managed quality assurance functions across two sites with 30% improvement in quality control testing.
• Established Technical Files and distributed CE Marked IVD devices ahead of schedule for smooth transition.
• Coordinated and established systems for international marketing, compliance, and product registration.

Manager, Regulatory Affairs, Cytosol Laboratories, Inc. (2001)

• Submitted and received approval for two New Drug Applications for blood processing pharmaceutical.
• Generated, submitted, and approval for CE Marking of anticoagulant product in EU for blood processing.
• Revised and streamlined auditing program for compliance to ISO 9001:2000 and management feedback.

Quality Assurance Compliance Manager, Lumenis/ESC Sharplan (2000-2001)

• Established Quality System components at new site that includes MRB, complaint handling, management review.
• Developed document system for Corporate documents to be used by multi-national facilities that held ISO 9000 certification and complaint handling systems specific with country regulations.
• Project Team Leader for IPL Treatment Heads reducing failure rate by 30% and reduced complaints by 50%.
• Developed and implemented organization wide Laser Safety Program with policies, procedures, and reporting.
• Established communications between different geographical sites with team building and communication.

Manager of Quality Assurance bioMérieux, Inc. (1998-2000)

• Established design control system for nucleic acid DNA probe tests. System developed to handle an entrepreneurial development site within a fast-paced development cycle.
• Developed Risk Analysis system compliant to ISO 14971 identifying high risk items and implemented mitigation.
• Implemented new document control system to approve and distribute documents electronically to organization.
• Created dynamic corrective action system to involve management and improved many systems by 50%.
• Developed company-wide training program for Design Control, GMPs, Documentation, and Risk Analysis.

Manager of Quality Assurance and Regulatory Affairs, Medtronic Gastroenterology Group/Zinetics Medical (1993-1998)

• Established Quality System and received ISO 9001 / EN 46001 certification first time with minor observations.
• Created Technical Files for Class IIb products and distributed CE Marked products ahead of deadline.
• Reduced complaints by 50% with corrective action systems and created significant customer focus process. Maintained a database and trend analysis of complaints for follow-up and management review.
• Built the Quality Assurance and Quality Control organized while integrating with corporate company policy.

Quality Assurance Compliance Manager,  Bard Access Systems, Division of C.R. Bard (1991-1993)

• Created and maintained calibration system with contract laboratory for over 800 pieces of equipment.
• Coordinated sterilization validation and established validation protocols and reports for continued compliance.
• Managed the document control system and created system to track status of changing procedures and policies.

CERTIFICATIONS:

• Certified Quality Auditor - CQA through American Society of Quality
• Certified Quality Technician - CQT through American Society of Quality
• Regulatory Affairs Certified (US and EU) through Regulatory Affairs Professional Society
• Member of American Society of Quality (ASQ)
• Member of Regulatory Affairs Professional Society (RAPS)
• Accreditations and certifications for Medical Device applications (cleanroom, sterilization, DOE)

AREAS OF EXPERTISE:

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 13485:2003 and ISO 9001:2000
• Canadian Medical Device Regulations (CMDR)
• Internal auditing for compliance and improvement
• 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:

• Bachelor of Science, Biomedical Biology, Bridgewater State College

HOME BASE:

• Florida, USA