Expert in quality and regulatory affaires for medical devices.
Help companies in preparing technical files and summaries (STED) for CE marking, or updating technical files and summaries.
Coordonne and document risk management activities (ISO 14971, IEC 60601, ICH Q9)
Write and /or review clinical evaluation report (MEDDEV 2.7.1), clinical follwup (MEDDEV 2.12)
Write and /or review biological evalaution (ISO 10993)
Interaction with notify bodies, local representative and authorities
Expertise with combination products (drug and drug delivery devices)
Broad therapeutic expertise: gynecology, endocrinology, ophtalmology, radiology, electrophysiology, immunology, arthritis, diabetes, end stage renal diseases, ...
AdaptabilityProblem solvingProactivityOptimismInterest in knowledgeIndependenceFlexibilityEfficiencyCuriosityCreative thinkingAuthenticityAnalytical thinkingStrategic thinking
Biochemistry Cell biology Diabetes Medical devices R&D Scientific writingActions and modes of action of drugs in the human speciesAllergy and immunologyAnimal ModelsBioavailabilityBiomarkersBiotechnologyCAPACardiovascular diseasesCell biologyDiabetesDiagnosticsDrug development processEndocrinologyEndocrinology and metabolismMedical DevicesMolecular & Cellular Biologymolecular biologypeople managementPre-clinical researchRegulatory RequirementsRheumatologyScientific WritingSearch literature on clinical trialsTeam LeadershipWomens Health
PhD in Biochemistry and Molecular Biology from Liège University in 1994