Your 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&D, Regulatory Affairs, Biocompatibility Specialists) on toxicological safety, material acceptability, and risk mitigation strategies
* Ensure regulatory compliance: Interpret and apply global requirements (EU MDR, FDA, NMPA, ISO standards) to toxicological evaluations and submissions
* Author and approve documentation: Prepare or review toxicological justifications, safety assessments, and Biological Evaluation Reports (BERs) to support product registrations
* Monitor emerging science and regulations: Track updates in toxicology, ISO 10993 standards, and regulatory guidance; 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)
Your Talents
* 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
Your Benefits
* Flexible working hours & mobile working: In many areas, working hours and location can be arranged as required
* 30 vacation days and various special payments
* Further training opportunities: Open in-house seminar program, extensive e-learning offering, professional development courses and much more
* Corporate benefits and bicycle leasing
* Subsidy for private pension plan and company health management
* Various childcare options – at the headquarters in Tuttlingen
* Health, sports, cultural and leisure activities – offers vary depending on location