Education:
Biochemist (Diploma)
PhD (Dr. rer. nat.)
Researcher and Lecturer at the Institute of Biochemistry and Institute of Medical Immunology, University Hospital Berlin (Charité)
Experience:
Consulting and management experience in IVD industries.
Compliance to new regulation (EU) 2017/746 (IVDR) and directive 98/79/EG (IVDD).
Development, Transfer and production of immuno assays including PoC, quality control and assurance, regulatory compliance.
Trainer for IVDR (e.g. TÜV Rheinland Akademie: Technical Documentation, Person responsible for regulatory compliance (PRRC), Post Market Surveillance & Vigilance)
Areas of Expertise:
Regulatory Affairs and Compliance, Chemistry, Manufacturing and Control