Rebecca Fuller

Experience

1. VP of Regulatory Compliance

   Qualityhub

   May 2020 — Present

   As a VP of Regulatory Compliance I am responsible for the oversight and execution of QualityHub\'s consulting services, including strategic planning, supervision of consultants, and ensuring deliverables consistently exceed client expectations. I provide technical and RA/QA guidance to our clients and our consulting team. What I love the most about my job is the opportunity to teach and mentor people who share my passion for biotech and developing creative solutions to complex problems. Im proud to have dedicated my career to improving public health by contributing to quality improvement and compliance of products that save lives.QualityHub, Inc. provides regulatory and quality consulting services to pharmaceutical, medical device, and biologic industries. We are recognized for the expertise and experience of our consulting team, many of whom are former FDA staff. With commitment to consistent quality of service, QualityHub has helped large and small life science companies successfully develop and implement quality systems, resolve regulatory enforcement actions, develop regulatory compliance strategies, and remediate documents and records such as DHFs, RMFs, CAPAs, Complaints, Supplier Files, etc. QualityHub has a long standing reputation for providing value-added audit services, including QMS audits, Mock FDA Inspections, Supplier Audits and due-diligence audits. We can provide technical and engineering expertise for a wide variety of pharma/device products and processes and offer training in all areas of regulatory compliance, quality management systems, Risk Management, FDA inspection planning and management, product/process validation methods, Root Cause Analysis, and compliance for combination products. Visit for more information.Click the link below to see full Curriculum Vitae for Rebecca.

Education

• University of Houston

  BS

Skills

• Medical Devices
• Capa
• Design Control
• Fda
• Quality Assurance
• Quality System
• Complaint Management & Ae Reporting
• Quality Auditing