Hortense Miersman
Regulatory Affairs Specialist @Cousin Surgery
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WORK HISTORY
Regulatory Affairs Specialist @Cousin Surgery
Project leader for the development of implantable devices in Europe (MDR) under the New Regulation 20•••45- Drafting and updating export dossiers for Australia, Korea, Thailand, Mexico, India and China- Regulatory team member for the development and marketing of an innovative device in South Korea- Implement the clinical and biological evaluation strategy for implantable medical devices- Validation of instructions for use, labels and promotional brochures- Substitute for vigilance and batch recall - Analysing the impact of a change within the company in accordance with regulatory guidelines- Regulatory support during ISO 13485, MDSAP, MDD and MDR audits (more than 5 audits performed)- Regulatory watch (MDSAP, Europe.)
EDUCATION
UFR3S - Département d'Ingénierie et Management de la Santé (ILIS) - Université de Lille
Licence, Sciences pour la Santé
Faculté de Médecine Henri Warembourg
Première Année Commune aux Etudes de Santé, Médecine
University of Montpellier
Master Ingénierie de la Santé, Parcours "Dispositif Médical : de la Conception à la Commercialisation"
Lycée Fénelon
Baccalauréat Scientifique, Option Physique-Chimie
ABOUT HORTENSE MIERSMAN
Regulatory Affairs Specialist
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