🧪 Toxikologe/in (m/w/d) im Bereich Regulatory Toxicology, Medical Writing & Beratung
Core
Conduct regulatory toxicology assessments, derive health-based limits (PDE, ADE, TTC), and evaluate biological safety for medical devices and pharmaceuticals.
Role type
Senior regulatory toxicologist (consulting)
Builds
Scientific and regulatory evaluations, Biological Evaluation Reports, and client advisory documents
Domain
Medical devices and pharmaceuticals regulatory compliance
Required skills
Human toxicology, regulatory requirements (MDR, ISO 10993), critical literature review, risk assessment, scientific writing, data analysis
Preferred skills
PhD, experience with Biological Evaluation Reports, experience with extraction/leachables data
Technologies
MDR, ISO 10993
Responsibilities
Research and analyze toxicological data from literature and databases; Derive health-based limits and evaluate substances/processes; Advise clients on biological safety and regulatory strategy; Lead projects with increasing experience
Seniority
Senior, hands-on IC