01.10.2025 aktualisiert
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IVD Expert and Regulatory Affairs Manager with 15 years experience in IVDs and Medical Devices.
Eschweiler, Deutschland
Weltweit
Diplom Ingenieur (FH) BiotechnologySkills
Medizinische GeräteMedizintechnikBiokompatibilitätBiomedizinische TechnikSoftwaredokumentationIec 62304Iso 13485ISO 14971ProjektmanagementMedical WritingBenannte StelleQualitätsmanagementTechnisches SchreibenTechnische DokumentationToxikologie
Senior IVD Expert and Regulatory Affairs Manager with 15 years experience in IVDs and Medical Devices.
- Project Leader and Team Leader
- IVDR / MDR / FDA
- Performance Studies
- Technical Documentation and Marked Authorization
- Communication with Notified Bodies and National Competent Authorities
- Post Market Survillance, Vigilance
- Market Authorization in US; Europe; Asia
- Biocomp; Toxicology; Medical Writing; Technical Writing; Performance Evaluation
- ISO 13485 (QMS Systems for Medical Devices)
- ISO 14971 (Risk Management)
- ISO 10993-1 (biocompatibility)
- DIN EN ISO 11135 (sterilization with ethylene oxide); DIN EN ISO 11137 (sterilization with radiation); DIN EN ISO 17665 (sterilization with moist heat); DIN EN 556-1 (labelling of sterile devices); DIN EN ISO 14937 (general requirements for the characterization of sterilizing agents and for the development, validation, and routine control of sterilization processes)
- DIN EN ISO 11607-2 (requirements for medical-device packaging, including validation of the packaging processes)
- ISO 17664-2:2021 (Reprocessing of reusable Instruments)
- IEC 60601-1 (el. Safety); IEC 60601-1-2 (EMC)
- IEC 62366-1 (Usability)
- IEC 62304 (software)
- ISO 15223-1 (symbols)
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2022
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
Project Management, Document Support, SOP writing
Biologische Evaluierung von Dialyse- und Hämofiltrationslösungen.
Biologische Evaluierung von Desinfektionsmitteln.