Bruce Prothro

Senior Vice President, Global Regulatory Affairs @Penumbra, Inc.

Fort Worth, TX, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jul 2021 — Present

Senior Vice President, Global Regulatory Affairs @Penumbra, Inc.

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Alameda, CA, US

EDUCATION

1980 — 1984

University of California, Berkeley

BS, Chemistry

SKILLS

R&DBiomedical EngineeringDesign of ExperimentsManufacturingCommercializationDmaicRegulatory SubmissionsGxpQuality AuditingSpcChange ControlQuality ControlGmpInjection MoldingQuality AssurancePmaIso 13485Root Cause Analysis21 CfrClinical TrialsIsoSopFdaBiotechnologyProcess EngineeringCe MarkingProduct DevelopmentTechnology TransferDesign ControlCathetersRegulatory RequirementsValidationClinical DevelopmentCross-Functional Team LeadershipSupplier QualityIso 14971Fmea21 Cfr Part 11Quality SystemV&V

ABOUT BRUCE PROTHRO

Hands-on, strategic medical device professional with over 30 years of experience offering a broad range of services to companies in various stages of growth, from venture backed start-ups to large global enterprises.Experience includes:• Developing, leading & executing key regulatory strategies for US, European & broader markets• Defining strategies & interacting with FDA & other global regulatory agencies• Designing & implementing Quality Management Systems compliant with all required regulations• Strategic development of key clinical studies• Building & leading global teams• Implementing systems & processes to complement existing & planned growth• Leading operations management, supply chain, procurement, manufacturing, site build-out• Executing design and process validation strategies• Expert testimony in product liability & patent infringement

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