Amsterdam Area, Netherlands
Head of Regulatory and Clinical Affairs at BSI
Medical Devices
Education
University of Twente 1993 — 1998
PhD, biomaterials - chemical technology
Universiteit Twente 1987 — 1993
MSc, Chemical Engineering, biomaterial sciences
Experience
BSI January 2015 - Present
BSI Germany NB0535 March 2013 - Present
Team-NB October 2011 - Present
BSI Eurocat May 2010 - Present
BSI September 2009 - Present
EMA/CAT and Medical Device Collaboration group 2009 - Present
NB-MED October 2006 - Present
RAPS October 2009 - January 2014
KEMA February 2003 - August 2009
KEMA Quality BV 2003 - August 2009
Skills
Project Management, Validation, Regulatory Submissions, Iso 9000, ISO 14971, Quality Management, Risk Management, Continuous Improvement, Clinical Trials, Quality Control, FDA, Design Control, GCP, Management, Leadership, R&D, Biomedical Engineering, Quality Assurance, Life Sciences, Biotechnology, V&V, ISO 13485, CE marking, Training, GMP, ISO 9000, Biopharmaceuticals, Sop, Regulatory Affairs, Policy, Clinical Research, Asia Pacific, Quality System, CAPA, Auditing, GLP, Healthcare, Pharmaceutical Industry, Quality Auditing, Strategy, Medical Device Directive, ISO, Medical Devices, Regulatory Requirements, Change Control, Lifesciences, 21 CFR Part 11