Jamie E. Mangold

About Jamie E. Mangold

Driving clinical quality and evidence strategy to enable regulatory readiness and market access for complex medical device portfolios. I oversee CERs, CEPs, and PMCF programs while also stepping in to execute key deliverables across high-priority initiatives. Skilled at mentoring teams, managing external consultants, and guiding cross-functional stakeholders to deliver compliant, audit-ready clinical evidence. I combine strategic oversight with hands-on execution, translating complex clinical data into actionable insights for regulatory and business decisions.

Experience

1. Director, Clinical Quality

   Varian

   Apr 2026 — Present

   Lead global clinical quality operations, preparing the organization for EU MDR, ISO 14155, FDA, and GCP compliance.Oversee clinical evidence strategy and PMCF programs across global portfolios.Mentor clinical teams and manage external CER consultants and writing services, ensuring resources are aligned for high-quality, compliant deliverables.Guide cross-functional stakeholders on evidence strategy and quality readiness.Oversee quality documentation, audit findings, CAPAs, and reporting of key metrics.

Education

• Indiana University of Pennsylvania

  BA, Psychology

  1998 — 2002

• University of Virginia

  PhD, Sensory and Systems Neuroscience

  2002 — 2007

Skills

• Editing
• Technical Writing
• Laboratory
• Cell
• Animal Models
• Scientific Writing
• Science
• Neuroscience
• Western Blotting
• Molecular Biology
• Fluorescence Microscopy
• Cell-Based Assays
• Research
• Confocal Microscopy
• Cell Biology
• Molecular Genetics
• Data Analysis
• Genetics
• Mitochondria
• In Vivo
• Writing
• Neuroanatomy
• Microscopy
• Clinical Research
• Publications
• Immunohistochemistry
• Qpcr
• Drug Discovery
• Pharmacology
• Cell Culture
• Life Sciences
• Assay Development
• Bioenergetics
• Laboratory Skills
• Pcr