Work Flexibility: Remote

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) preferred
• 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​

Carsten Engel | Recruiter Talent Acquisition

Carsten.Engel@karlstorz.com