Über 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.
Polnisch
Muttersprachlich oder zweisprachig
Englisch
Verhandlungssicher
Französisch
Konversationssicher
Vor Ort möglich
Nyon (bis zu 50 km)
Projekt- und Berufserfahrung
- Effectum MedicalMedical Device ExpertMEDIZINJanuar 2026 - Heute (5 Monate)Olten, SchweizSupporting 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 AssistantMEDIZINSeptember 2025 - Heute (9 Monate)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 DevelopmentFORSCHUNGJuli 2024 - August 2025 (1 Jahr und 1 Monat)• Contributed to the STELLA project, designing a low‑cost radiotherapy knowledge‑transfer framework for LMICs
Empfehlungen
Sei die erste Person, die Wioletta empfiehlt
Teile Deine Erfahrung aus der Zusammenarbeit mit diesem Freelancer.
Diese Freelancer passen auch zu Ihren Kriterien
Agatha Frydrych
Backend Java Software Engineer
4.7
(3)
2
Baptiste Duhen
Fullstack developer
4.6
(4)
5
Amed Hamou
Senior Lead Developer
4
(2)
7
Audrey Champion
Web developer
4.3
(3)
4
Ausbildung und Abschlüsse
- 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
Fähigkeiten
Kategorien
- Sonstige