Produktexpert*in In-vitro-Diagnostika (w/m/d) / 17297
Core
Evaluate technical documentation and test results for In-vitro-Diagnostic (IVD) products to ensure compliance with EU regulations (IVDR) and international standards.
Role type
Senior Product Expert (IVD)
Builds
Compliance assessments and certification reports for IVD manufacturers
Domain
Medical Devices / In-vitro-Diagnostics
Deliverable
client delivery
Required skills
IVD regulatory knowledge (IVDR), technical documentation analysis, risk assessment, change management, root cause analysis, report writing
Preferred skills
Background in Biochemistry, Chemistry, Medical Engineering, or Biomedical Laboratory Diagnostics
Technologies
IVDR, ISO 13485
Responsibilities
Review technical documentation and test results for production batches up to highest risk class; Assess IVD products and manufacturer documentation against EU regulations; Evaluate reports on product changes and incidents; Create conformity assessment reports; Serve as central contact for evaluation and certification projects
Seniority
Senior, hands-on IC