2024 -
now Company Owner Senior Consultant @ RS MedTech
2020 -
2025 Global Vice President Regulatory. Quality and Clinical Affairs @
2014 -
2020 Executive Vice President Quality Assurance and Regulatory and Clinical Affairs @
2010 -
2014 VP Regulatory Affairs and Quality @
2006 -
2010 QARA Leader Field Regulatory and Compliance @
2006 -
2010 Vice President Global Quality @
Robert Steele Education
The Open University
BA (Electro-Mechanical Engineering)
1985
-
1990
Robert Steele Skills
ISO 13485
ISO 14971
CAPA
CE marking
FDA
Design Control
21 CFR
Medical Devices
ISO
Medical Device Directive
Quality Management
Quality System
Root Cause Analysis
IEC 60601
Validation
Regulatory Submissions
Change Control
GMP
Regulatory Affairs
V&V
21 CFR Part 11
Biomedical Engineering
Biocompatibility
Quality Assurance
Clinical Trials
Computer System Validation
Technology Transfer
DMAIC
Pharmaceutical Industry
Biotechnology
Quality Auditing
Complaint Management
R&D
Quality System Compliance
PMA
FDA GMP
Design of Experiments
Supplier Quality
Post Market Surveillance
CQA
Gage R&R
Clinical Development
Complaint Investigations
Regulatory Requirements
Commercialization
Biologics
Hardware Diagnostics
Biomaterials
GxP
Quality Control
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 ISO 13485, ISO 14971, CAPA, CE marking, FDA and more. Robert Steele has 1 emails and 3 mobile phone numbers on RocketReach.
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