Haven McCall

Board Member @Bioutah

Salt Lake City, UT, US
EMAILS
h••••••@jhu.edu
MOBILE NUMBERS
+18•••••••64

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WORK HISTORY

Oct 2023 — Present

Board Member @Bioutah

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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

N/A

University of Southern California

Doctorate (DRSc), Regulatory Science

N/A

University of Southern California

Master of Science (MSc), Regulatory Science

N/A

Northern Arizona University

Masters in Business

SKILLS

Product DevelopmentDmaicOperational ExcellenceRegulatory SubmissionsCross-Functional Team LeadershipIso 13485Supplier QualityIso 14971Continuous ImprovementComplianceR&DRegulatory AffairsRegulatory RequirementsDesign ControlChange ControlProgram ManagementQuality SystemV&VDesign of ExperimentsManufacturing21 Cfr Part 11Medical DevicesClinical ResearchCapaSix SigmaProduct LaunchGxpIso 9000Quality AuditingTrainingQuality ControlGmpStrategyBiomedical EngineeringIsoPharmaceutical IndustrySopFdaBiotechnologyLean Manufacturing

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.

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