Hester Knol
Senior Clinical Operations and Regulatory Affairs Manager @Herodikos
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WORK HISTORY
Senior Clinical Operations and Regulatory Affairs Manager @Herodikos
Oldenburg, DE
Achieved MDR Class I product registration and implemented ISO 13485-compliant QMS.• Serving as PRRC, ensuring regulatory compliance and post-market surveillance.• Authored key clinical documents: CER, PMCF, CIP/CIR.• Leading clinical operations and R&D across cross-functional teams• Implemented and certified ISO/IEC 27001 ISMS; serving as Information Security Officer.
EDUCATION
University of Groningen
Bachelor, Human Movement Sciences
Aix-Marseille University
Doctor of Philosophy (Ph.D.), Perception, action and motor control
University of Groningen
Master, Human Movement Sciences
CBM Projektmanagement GmbH
Project Management IPMA Level D
CSG Comenius, Leeuwarden
VWO, Natuur en Gezondheid
SKILLS
ABOUT HESTER KNOL
A human movement scientist (Ph.D), certified project manager (IPMA, SCRUM), Information Security Officer (ISO), Person Responsible for Regulatory Requirements (PRRC) and Clinical Operations Manager, with leadership, project management and consultant experience in international organisations. Enthusiastic public speaker in 5 languages: speeches at non-scientific meetings as well as scientific presentations and lectures. A special heart for team work and an efficient organiser.
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