Biologe (m/w/d)
Core
Conduct systematic literature research and create reports on scientific validity and state of the art to support clinical performance evaluation and product regulatory approval.
Role type
Junior Scientific Affairs Manager (Regulatory Affairs)
Builds
Clinical evidence documentation and regulatory dossiers for in-vitro diagnostic products
Domain
In-vitro diagnostics / Clinical laboratory medicine
Required skills
Systematic literature research, Scientific report writing, IVDR compliance knowledge, Clinical evidence documentation, Post-market performance follow-up, Technical documentation maintenance, Quality management processes, Analytical thinking, Conceptual skills, Structured problem solving
Preferred skills
Molecular genetics knowledge, Immunohistochemistry knowledge, Self-initiative, Team collaboration
Technologies
IVDR, IVD, ISO standards, SOPs
Responsibilities
Conduct systematic literature research, Create reports on scientific validity and state of the art, Create and maintain IVDR-compliant clinical evidence documentation, Support Post-Market Performance Follow-up activities, Assist in maintaining technical product documentation and databases, Ensure compliance with regulatory and legal requirements, Participate in quality management processes
Seniority
Junior, hands-on IC