Job Description

Job Function: Research & Development
Location:
Tuttlingen, BW, DE, 78532
Work Location (for field-based positions):
Work Flexibility: Remote
Job ID: 4747
#

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

HR Contact

--------------


Carsten Engel | Recruiter Talent Acquisition
Carsten.Engel@karlstorz.com
4747