À propos de Wioletta
Biomedical Engineer and Medical Physicist with PhD specializing in Radiotherapy and Medical Devices. Experienced in clinical trial management, eQMS systems (ISO 13485, MDR, IVDR), regulatory-compliant medical device documentation and R&D leadership. Ideal for roles in MedTech innovation, or clinical research where precision and regulatory excellence matter.
Bringing 5+ years at ADAM S.A. and CERN, plus publications in Physics in Medicine and Biology related to complex research simulations, delivering validated radiotherapy calculations.
Polonais
Bilingue ou natif
Anglais
Capacité professionnelle complète
Français
Capacité professionnelle limitée
Accepte de travailler sur site
Nyon (jusqu’à 50 km)
Expériences
- Effectum MedicalMedical Device ExpertSECTEUR MÉDICALjanvier 2026 - Aujourd'hui (5 mois)Olten, SuisseSupporting MedDev submissions for EU market certification and evaluating comprehensive technical documentation. Preparing and implementing eQMS systems compliant with ISO 13485, MDR, and IVDR standards. Managing change processes for existing legal manufacturing contracts to ensure regulatory alignment.
- HeroSupport S.A.;Regulatory and Clinical Affairs AssistantSECTEUR MÉDICALseptembre 2025 - Aujourd'hui (9 mois)Geneva, SwitzerlandProject management of clinical investigations for Class I medical devices (breast support for radiotherapy), ensuring documentation compliance with EU MDR, FDA 21 CFR, and Swiss MedDO regulations. Focus on strategic planning, data management protocols, and ethics committee submissions. Preparation of Ethics Committee submission documents including Clinical Investigation Plan (CIP), Case Report Forms (CRFs), and Informed Consent Forms (ICF).Supporting preparation for CE certification.
- CareerBreakCareer Break for Professional and Personal DevelopmentCENTRES DE RECHERCHEjuillet 2024 - août 2025 (1 an et 1 mois)• Contributed to the STELLA project, designing a low‑cost radiotherapy knowledge‑transfer framework for LMICs
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Formations
- Diploma of Advanced Studies (DAS) in Management of Clinical TrialsUniversity of Geneva2026Diploma of Advanced Studies (DAS) in Management of Clinical Trials
- PhD in Medical PhysicsMedical University of Vienna2023PhD in Medical Physics
Compétences
Catégories
- Autre