Regulatory Affairs @ Medtronic (retired) (January 2011 - July 2023)
Regulatory Affairs @ CSI (February 2008 - December 2010)
Regulatory Affairs @ (January 1999 - January 2008)
Department Manager, Orthopedic devices @ FlexMedics (January 1991 - January 1996)
David Brooke Education
Purdue University
BSME
1979-1983
David Brooke Skills
Supplier Quality
DMAIC
ISO
R&d
Clinical Trials
Regulatory Affairs
Design of Experiments
ISO 13485
Medical Devices
V&V
Strategic Planning
ISO 14971
SPC
Minitab
Project Management
FDA
Manufacturing
Cross Functional Team Leadership
Marketing
Design Control
Medical Device Directive
Pharmaceutical Industry
21 CFR
FMEA
Product Development
CAPA
Root Cause Analysis
Program Management
GMP
Validation
Quality Auditing
Six Sigma
Quality System
CE marking
Biomedical Engineering
Microsoft Excel
Commercialization
PMA
Regulatory Requirements
David Brooke Summary
David Brooke, based in North Branch, MN, US, is currently a Regulatory Affairs Consultant at Independant. David Brooke brings experience from previous roles at Medtronic (retired), CSI, Boston Scientific and FlexMedics. David Brooke holds a 1979 - 1983 BSME @ Purdue University. With a robust skill set that includes Supplier Quality, DMAIC, ISO, R&d, Clinical Trials and more. David Brooke has 1 mobile phone numbers on RocketReach.
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