About Severine
French
Native or bilingual
English
Fluent
Spanish
Conversational
German
Basic
Experience
- BioSciences GmbHVice-President, Medical and Regulatory AffairsMEDICALOctober 2022 - January 2024 (1 year and 3 months)Dubai, United Arab Emirates- In charge of planning and execution of Medical and Regulatory Strategies- Responsible for Medical Information and Communication, Training and Clinical evidence generation- Overseeing registration process world wide (EU, LATAM, Middle East, Africa, Asia, Australia- In charge of coordination of CER writing
- Eclevar MedTechConsultantMEDICALOctober 2019 - October 2020 (1 year)Paris, France- Accompagnement d’entreprises de dispositifs médicaux (classes I, II, III) dans la conformité MDR, incluant l’élaboration et la revue des plans PMCF et des rapports d’évaluation clinique.- Collaboration avec les équipes pour garantir la précision documentaire et le respect réglementaire.- Résultats de remédiation concluants pour des entreprises de dispositifs médicaux de tailles variées.
- i-SEEDDIndependent Consultant in Medical Affairs and Clinical TrialsMEDICALJanuary 2019 - Today (7 years and 5 months)Dubai, United Arab EmiratesPunctual or long-term support to small/mid-size organizations in increasing medical knowledge & its use + developing clinical trials/local initiatives by:- Medical congress attendance, Medical watch on specific topics and report- Support in organizing Scientific Advisory Board- Medical writing- Training & education on scientific topics including HEOR- Assessment of clinical sites- Review of Clinical Evaluation Reports (CERs) for medical devices- Support in strategy and conduct of PMCF (Post-Market Clinical Follow-up) for medical devices
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Education
- Health Economics Basics,BUSINESS SCHOOL2014Health Economics Basics,
- PharmDSchool of Pharmacy, Châtenay-Malabry, Paris XI.2003