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Robert van Boxtel Location
Gelderland, Netherlands
Robert van Boxtel Work
Principal Consultant @ (January 2016 - Present)
Sr. Consultant @ (September 2010 - December 2015)
Chair RAPS European Council @ (January 2025 - Present)
Board Member RAPS NL Chapter @ (July 2018 - Present)
Vice Chair RAPS European Council @ (December 2022 - January 2025)
RAPS European Council member @ (September 2020 - December 2022)
Sr. Project Manager Certification Medical devices. Product Expert 510(k) - 3th party reviewer. @ (February 2003 - September 2010)
Production Technology @ Pharmacia Groningen (January 1998 - January 2003)
R and D @ Pharmacia Iovision Inc (January 1996 - January 1998)
Robert van Boxtel Education
University of Twente
MSc (Biomedical Material Technology)
1987-1994
Pius X College, Almelo 1982-1987
Robert van Boxtel Skills
21 CFR Part 11
510 K
Account Management
Business Process Improvement
CAPA
CE marking
CQA
Change Control
Complaint Handling
Design Control
Disposables
FDA
FMEA
ISO
ISO 13485
ISO 14971
ISO Standards
Iso 9000
MDD
Management Review
Manufacturing
Medical Device Directive
Medical Devices
Process Improvement
Process Validation
QSR
Quality Assurance
Quality Auditing
Quality Control
Quality Engineering
Quality Management
Quality System
Quality Systems
R&D
Regulatory Affairs
Regulatory Requirements
Regulatory Submissions
Risk Management
Start-ups
U.S. Food and Drug Administration (FDA)
V&V
Validation
Validations
Leadership
Regulations
Sales
Start Ups
Business Analysis
Marketing
Customer Service
Management
Radiology
Integration
u.s. Food and Drug Administration Fda
u.s. Food and Drug Administration
Robert van Boxtel Summary
Robert van Boxtel, based in Gelderland, Netherlands, is currently a Principal Consultant at MDProject. Robert van Boxtel brings experience from previous roles at MDProject and Regulatory Affairs Professionals Society (RAPS). Robert van Boxtel holds a 1987 - 1994 MSc in Biomedical Material Technology @ University of Twente. With a robust skill set that includes 21 CFR Part 11, 510 K, Account Management, Business Process Improvement, CAPA and more. Robert van Boxtel has 3 emails on RocketReach.
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