<html> <body> Richard Vincins </body> </html>

Richard Vincins

VP, Global Regulatory Affairs

Richard brings more than 30 years of global medical device, IVD, and pharmaceutical quality and regulatory experience to each customer engagement, employing his extensive expertise in regulatory strategy, regulatory classifications and submissions, risk management, software-driven products, postmarket surveillance, complaint handling, adverse event reporting, inspection readiness, and auditing.

As the key leader in global regulatory affairs for Oriel STAT A MATRIX, Richard has supported medical device organizations of all sizes to understand the changes in worldwide device regulations and how they will affect their compliance gaps, and to plan for and implement their transition to changes in regulations.

Richard has developed a suite of proprietary tools that assist our clients in meeting worldwide regulatory compliance and successful product regulatory submissions.

Richard at a Glance

Audit Expertise

  • EU Medical Devices Regulations
  • EU IVDR
  • ISO 13485
  • MDSAP
  • 21 CFR 820
  • 21 CFR 806
  • 21 CFR 803
  • 21 CFR 211

QMS Process Expertise

  • PREMARKET
    • Design Control
    • Document Control
    • ISO 14971/Risk Management
    • IEC 62366/Human Factors
    • IEC 60601/Electrical Requirements for Medical Devices
    • IEC 62304/Software Validation
  • PRODUCTION
    • ISO 14971/Risk Management
    • Process Validation
    • Production & Process Control
    • Supplier Controls
    • Document Controls
  • POSTMARKET
    • ISO 14971/Risk Management
    • CAPA
    • Complaint Handling and Medical Device Reporting
    • Supplier Controls
    • Document Controls
    • Clinical Evaluation Reports
    • Postmarket Surveillance
    • FDA 483 Remediation
    • FDA Warning Letter
    • FDA Consent Decree
    • NB Major Observations

Regulatory Submissions

  • Experience with submissions across device classes in USA, Canada, Europe, Japan, China, Brazil, and Australia

Education

  • BS, Biomedical Biology – Bridgewater State College

The Oriel STAT A MATRIX consulting team averages 25+ years of life sciences industry experience and has deep expertise in US, European and global RA/QA requirements.

Richard’s Areas of Expertise

  • Regulatory – Has been the key subject matter expert for EU MDR and EU IVDR courses, including implementation of, auditor training for, and clinical evaluation report training for EU MDR. Also, has mentored and coached staff and peers presenting extensive training on regulatory and quality topics.
  • Quality Management Systems – Implemented 35 quality management systems compliant to FDA QSR, ISO 13485, Medical Device Directive, and CMDCAS requirements, achieving successful certifications and/or accepted inspection results.
  • Auditing – Conducted over 200 quality management system audits, including internal audits, supplier audits, due diligence audits, and gap assessment audits. In addition, Richard has managed or assisted in 80-plus registrar or Notified Body audits for ISO 9001, ISO 13485, EU MDR, and CMDCAS requirements, achieving successful certifications and/or accepted inspection results.
  • Training – Developed content from regulatory requirements and has delivered numerous trainings on topics ranging from regulatory requirements to quality system tools.

Highlighted Experience

  • Led teams for risk management in compilation, review, approval, and updating of over 100 risk management files across 40 different product types.
  • Piloted a global training initiative for a large medical device company that needed to ready its worldwide RA/QA personnel to be prepared for the new EU MDR regulations.
  • Responsibilities included reviewing and updating QMSs obtaining ISO 13485 certification, leading a team for launching a new device platform according to the project timeline, completing international registrations that included CE Marking, and overseeing an FDA inspection that led to no observations.
  • Served as regulatory lead for introducing to market an aesthetic combination product injected into dermis as a Class II/IIb under private labeling, compiling necessary regulatory strategy and technical submission content. Responsibilities included reviewing marketing literature for claims and indications for use; providing regulatory strategy for the QMS, CE Marking, and technical documentation for a private-labeled device; completing final labeling review; and ensuring successful classification and approval with a Notified Body for a private-label CE Mark.

Other

  • Richard is a voting member of ISO US Technical Advisory Groups (TAG) 176 for Quality Management Systems (ISO 9001) and 302 for Auditing Management Systems (ISO 19011).

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