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 and ISO .

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).

Mission

• Conduct and review toxicological risk assessments (TRA): Evaluate chemical characterization data, extractables/leachables, and potential patient exposure scenarios in line with ISO and ISO .
• 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).

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 & 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.

Job Details

• Seniority level: Mid-Senior level.
• Employment type: Full-time.
• Job function: Research, Analyst, and Information Technology.
• Industry: Medical Device.

#J-18808-Ljbffr