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Kate Leith

EVP, Consulting and Education

Kate Leith has over 30 years of technical and management experience in medical device, IVD, and biologics industries with expertise in quality, program management, training, auditing, and regulatory support.

Her experience spans the entire product life cycle, from design to postmarket. As EVP for Oriel STAT A MATRIX, Kate oversees the technical aspects of the business, providing strategy and managing execution for our portfolio of services.

Kate at a Glance

Regulatory Expertise

  • Contributed to 510(k), PMA for IVDs
  • Brazil, Japan, Canada, US, and Australian regulations
  • China Order 650, 680

Audit Expertise

  • EU Medical Device Directive/Regulations
  • EU IVDD/IVDR
  • ISO 13485
  • MDSAP
  • 21 CFR 820, 803, 806
  • 21 CFR 210, 211
  • Performance-Based Auditing
  • Process-Based Auditing

QMS Process Expertise

  • Design Control
  • Clinical investigations
  • ISO 14971/Risk Management
  • Process Validation
  • Test Method Validation
  • Production and Process Control
  • Supplier Control
  • Document Control
  • Calibration
  • CAPA
  • Root Cause Analysis
  • Complaint Handling and Vigilance Reporting
  • Postmarket surveillance

Education

  • MS, Immunology &Microbiology, University of Louisiana
  • MBA, Southern New Hampshire University
  • BGS, Chemistry Conc., University of Indiana
  • AAS, Computer Science, Hennepin Technical 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.

Kate Leith Areas of Expertise

  • Regulatory – Responsible for the development of training related to FDA QSR, ISO 13485, MDSAP, China, EU MDR, EU IVDR, ISO 14971, and more. Kate holds the Regulatory Affairs Certification for Medical Devices (RAC-Device) credential.
  • Auditing – Provides oversight to the consulting division of Oriel STAT A MATRIX, with a focus on audits. Has conducted or overseen audits on quality management systems to assess compliance to a wide variety of regulations and standards, including EU MDR, EU IVDR, MDSAP, ISO 13485, and FDA QSR. Kate holds Certified Biomedical Auditor (CBA) and Certified Quality Auditor (CQA) credentials as well as Lead Auditor ISO 13485:2016.
  • Training – Oversees the company’s extensive library of training courses – both standard training and courses developed exclusively for clients seeking customized training solutions. Has developed and delivered training on a broad range of regulatory, auditing, and medical device-related subjects. She is also a popular instructor, scoring an average of 6.8 out of 7.0 for training delivery, topic knowledge, and overall classroom experience. Kate holds Certified Professional in Learning and Performance (CPLP) credential.

Highlighted Experience

  • Conducted learning gap analyses, identified training objectives, designed curricula, and deployed training and train-the-trainer programs around the world for complex technical topics.
  • Managed product development with third-party partner companies in the US and Europe, providing clear, well-defined expectations aligned with corporate objectives, and holding all parties accountable to schedule, budget, and quality requirements.
  • Developed, transferred, commercialized, and supported several IVD products, including reagents, software and instrumentation. Technical focus in immunoassays and molecular diagnostics. US and Global patent holder. Provided significant technical support for orthopedic product remediation.
  • Conducted several gap assessments and audits to aid clients in QMS development and improvement projects, leading to greater organizational efficiency and compliance.

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