Global Vice President Regulatory. Quality and Clinical Affairs @ (November 2020 - December 2025)
Executive Vice President Quality Assurance and Regulatory and Clinical Affairs @ (August 2014 - October 2020)
VP Regulatory Affairs and Quality @ (July 2010 - August 2014)
QARA Leader Field Regulatory and Compliance @ KCI Medical (July 2006 - September 2010)
Vice President Global Quality @ KCI Medical (July 2006 - July 2010)
Robert Steele Education
The Open University
BA (Electro-Mechanical Engineering)
1985-1990
Robert Steele Skills
21 CFR
21 CFR Part 11
510K author, submission support through to clearance.
Biocompatibility
Biologics
Biomaterials
Biomedical Engineering
Biotechnology
CAPA
CE marking
CQA
Change Control
Clinical Development
Clinical Trials
Commercialization
Complaint Investigations
Complaint Management
Computer System Validation
DMAIC
Design Control
Design of Experiments
FDA
FDA GMP
GMP
Gage R&R
GxP
Hardware Diagnostics
IEC 60601
ISO
ISO 13485
ISO 14971
Medical Device Directive
Medical Devices
PMA
Pharmaceutical Industry
Post Market Surveillance
Quality Assurance
Quality Auditing
Quality Control
Quality Management
Quality System
Quality System Compliance
R&D
Regulatory Affairs
Regulatory Requirements
Regulatory Submissions
Root Cause Analysis
Supplier Quality
Technology Transfer
V&V
Validation
Strategic Planning
Risk Management
Project Management
Training
Leadership
Microsoft Excel
Robert Steele Summary
Robert Steele, based in Kalamazoo, MI, US, is currently a Company Owner Senior Consultant at RS MedTech . Robert Steele brings experience from previous roles at Colfax Corporation, ConvaTec, Stryker Medical and KCI Medical. Robert Steele holds a 1985 - 1990 BA in Electro-Mechanical Engineering @ The Open University. With a robust skill set that includes 21 CFR, 21 CFR Part 11, 510K author, submission support through to clearance., Biocompatibility, Biologics and more. Robert Steele has 1 emails and 3 mobile phone numbers on RocketReach.
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