Toxicologist (m/f/d)

Conduct and review toxicological risk assessments (TRA): Evaluate chemical characterization data, extractables/leachables, and potential patient exposure scenarios in line with ISO 10993-17 and ISO 10993-18. Provide expert scientific guidance: Advise cross-functional teams (R integrate changes into internal processes and strategies. Act as escalation point: Provide independent toxicological expertise in complex or high-risk cases (e.g., novel materials, borderline exposure scenarios, pediatric indications). Mission Conduct and review toxicological risk assessments (TRA): Evaluate chemical characterization data, extractables/leachables, and potential patient exposure scenarios in line with ISO 10993-17 and ISO 10993-18. Provide expert scientific guidance: Advise cross-functional teams (R integrate changes into internal processes and strategies. Act as escalation point: Provide independent toxicological expertise in complex or high-risk cases (e.g., novel materials, borderline exposure scenarios, pediatric indications). Requirements Advanced degree (M.Sc. or Ph.D.) in Toxicology, Pharmacology, Biology, Chemistry, or related life sciences; recognized certification (e.g., ERT – European Registered Toxicologist) needed. Minimum 3–5 years of professional experience in toxicological risk assessment, preferably in the medical device, pharmaceutical, or related regulated industry. Strong understanding of ISO 10993 series, ISO 14971 (risk management), and global regulatory requirements (EU MDR, FDA, NMPA). Proven skills in toxicological data evaluation, chemical characterization, and exposure assessment, including extractables/leachables. Ability to interpret complex datasets, apply weight-of-evidence approaches, and provide clear safety justifications. Strong written and verbal skills; ability to explain complex toxicological concepts to non-experts and work effectively in cross-functional teams. Proactive in keeping up with scientific literature, evolving standards, and regulatory expectations. Benefits Flexible working hours