1998 -2014 Chief Regulatory Officer and Senior Vice President, Quality Systems and Assurance @
1992 -1998 Director, Regulatory Affairs and Quality Assurance @ KeraVision
1988 -1992 Manager, Quality Engineering @ Advanced Cardiovascular Systems
1985 -1988 Manager, Manufacturing @ Diamon Images
Bruce Prothro Education
University of California, Berkeley
BS (Football)
1980-1984
Bruce Prothro Skills
Manufacturing
Quality Assurance
Medical Devices
ISO 13485
Design Control
FDA
CAPA
Quality System
ISO 14971
V&V
Validation
GMP
Regulatory Affairs
Design of Experiments
R&D
CE marking
Product Development
Quality Control
Supplier Quality
Catheters
SPC
21 CFR Part 11
Quality Management
FMEA
Biotechnology
Change Control
Biomedical Engineering
Root Cause Analysis
Regulatory Submissions
Cross-functional Team Leadership
Process Engineering
Clinical Trials
ISO
DMAIC
Commercialization
Sop
Quality Auditing
Technology Transfer
Process Simulation
GxP
Clinical Development
Minitab
Testing
Sterilization
Regulatory Requirements
PMA
Iso 9000
Injection Molding
21 CFR
Manufacturing Operations
Supplier Quality Engineering
Development
Keys
Regulatory
Cross Functional Team Leadership
Clinical Affairs
Design
Quality Systems
Medical Affairs
Bruce Prothro Summary
Bruce Prothro, based in Fort Worth, TX, US, is currently a Senior Vice President, Global Regulatory Affairs at Penumbra, Inc.. Bruce Prothro brings experience from previous roles at Prothro Family Wines, SI-BONE, Inc., Prothro Consulting Group and Smith & Nephew. Bruce Prothro holds a 1980 - 1984 BS in Football @ University of California, Berkeley. With a robust skill set that includes Manufacturing, Quality Assurance, Medical Devices, ISO 13485, Design Control and more. Bruce Prothro has 3 emails on RocketReach.
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