02.10.2026 aktualisiert
100 % verfügbar
Product Owner & Design Responsible for IVD Devices
Freiburg im Breisgau, Deutschland
Weltweit
Dr. rer. nat.Über mich
• 4+ years at a leading company for automated IVD of autoimmune diseases • Production process design • Quality management following ISO13485, part. Changes, (p)FMEAs, CAPAs, and NCs • IVDR Technical Documentation and FDA pre-subs • Guideline implementation in V&V Study SOPs (e.g. CLSI Guidelines)
Skills
Data AnalysisAutomatisierungBiochemieBioinformatikMolekularbiologieKorrektur- und VorbeugemaßnahmeChange ControlMedizinische DiagnostikVersuchsplanungDifferentialdiagnostikEnzymeR (Programmiersprache)IndustrieproduktionIso 13485Labor-Management-System
IVD Product Development
Automated IVD development for autoimmune diseases with production process design and qualification of production equipment
Regulatory Affairs
Technical documentation according to IVDR, FDA pre-submissions, and implementation of V&V Study SOPs
Quality Management
Quality management following ISO13485 with change control, risk analysis, CAPAs, and non-conformities management
Assay Design
Enzyme assays development from early phases to launch with experimental design for V&V stages
Bioinformatics
Data analysis in R for material risk analysis and biostatistics applications
Laboratory Management
Laboratory operations in molecular biology and cell biology research environments
Scientific Research
Research experience in phosphatase biochemistry and molecular biology with multiple publications
Project Management
Project coordination from early design phases to post-market surveillance
Automated IVD development for autoimmune diseases with production process design and qualification of production equipment
Regulatory Affairs
Technical documentation according to IVDR, FDA pre-submissions, and implementation of V&V Study SOPs
Quality Management
Quality management following ISO13485 with change control, risk analysis, CAPAs, and non-conformities management
Assay Design
Enzyme assays development from early phases to launch with experimental design for V&V stages
Bioinformatics
Data analysis in R for material risk analysis and biostatistics applications
Laboratory Management
Laboratory operations in molecular biology and cell biology research environments
Scientific Research
Research experience in phosphatase biochemistry and molecular biology with multiple publications
Project Management
Project coordination from early design phases to post-market surveillance
Erfahrung
Berufserfahrung5 - 10 Jahre
Freelancer seit2025
Sprachen
DeutschMutterspracheEnglischverhandlungssicherFranzösischGrundkenntnisse
Projekthistorie
Product ownership and design responsibility for IVD devices with focus on automated systems for autoimmune disease diagnostics
Research and development of assay designs for diagnostic applications
Postdoctoral research in Prof. Dr. Maja Köhn laboratory