11.09.2025 aktualisiert
100 % verfügbar
IVDR and MDR Expert
Eschweiler, Deutschland
Deutschland
Diplom-BiologieSkills
ForschungMedizinische GeräteAuditsMedizinische ForschungKlinische PharmazieSoftwaredokumentationQualitätsmanagementRegulatory AffairsRisikomanagement
Biologist (Dipl. Bio.) with over 20 years’ experience in medical research at different international Institutes and within Medical
Devices Industry.
Supporting VYSYO – customers with her knowledge of Internal and External Auditing, International Regulatory Affairs, Risk management, Quality Management and Technical Documentation.
Devices Industry.
Supporting VYSYO – customers with her knowledge of Internal and External Auditing, International Regulatory Affairs, Risk management, Quality Management and Technical Documentation.
Sprachen
DeutschMutterspracheEnglischverhandlungssicherNorwegischgut
Projekthistorie
Clinical / Performance Evaluation
Regulatory Compliance
Clinical SOP development
Regulatory Compliance
Clinical SOP development
Remediation von NC / CAPA, Regelkonformität, Entwicklung von SOPs und Verbesserung der QMS, Schulungen und Effektivitätschecks, Management von CAPA und Production QA.