Haven McCall

About Haven McCall

I have worked in the biologics, medical device, and drug industry for 26 years in the areas of product development, scientific and technical consulting, quality, regulatory, clinical research, and laboratory testing. In addition to my work experience, I teach graduate level courses about FDA regulations at Johns Hopkins University.I am passionate about the life science industry and grateful for wonderful people I have met throughout my career.

Experience

1. Board Member

   Bioutah

   Oct 2023 — Present · Salt Lake City, UT, US

   BioUtah is an independent, non-profit trade association serving the life sciences community in the state of Utah. We are comprised of manufacturers and developers of medical devices, pharmaceuticals, diagnostics and biotechnology products as well as government, academic and health care institutions all focused on improving health and wellness through the delivery of innovative technologies and services. We are passionately focused on advancing and growing Utah’s life sciences industry and encourage collaboration and innovation amongst our members.

Education

• University of Southern California

  Doctorate (DRSc), Regulatory Science

• University of Southern California

  Master of Science (MSc), Regulatory Science

• Northern Arizona University

  Masters in Business

Skills

• Product Development
• Dmaic
• Operational Excellence
• Regulatory Submissions
• Cross-Functional Team Leadership
• Iso 13485
• Supplier Quality
• Iso 14971
• Continuous Improvement
• Compliance
• R&D
• Regulatory Affairs
• Regulatory Requirements
• Design Control
• Change Control
• Program Management
• Quality System
• V&V
• Design of Experiments
• Manufacturing
• 21 Cfr Part 11
• Medical Devices
• Clinical Research
• Capa
• Six Sigma
• Product Launch
• Gxp
• Iso 9000
• Quality Auditing
• Training
• Quality Control
• Gmp
• Strategy
• Biomedical Engineering
• Iso
• Pharmaceutical Industry
• Sop
• Fda
• Biotechnology
• Lean Manufacturing