Work Flexibility: Hybrid

Your Mission

• Manage and maintain material data: Collect, structure, and update material information (composition, specifications, certificates, safety data sheets) in dedicated databases and systems
• Support biological evaluation: Provide accurate and complete material data to Biocompatibility Specialists and Toxicologists for ISO 10993 assessments and Biological Evaluation Reports
• Ensure regulatory compliance: Verify that material documentation aligns with global regulatory requirements (EU MDR, FDA, NMPA) and internal procedures
• Coordinate with suppliers: Request, review, and track material declarations, certificates, and compliance statements (e.g., RoHS, REACH, USP Class VI, ISO 10993)
• Act as knowledge hub: Serve as point of contact for questions on material composition, changes, and related risks within projects
• Monitor changes and updates: Ensure timely updates when suppliers, manufacturing processes, or regulations change, maintaining traceability and consistency
• Contribute to risk assessments: Provide material-related input for device family matrices, worst-case justifications, and change-control evaluations

Your Talents

• Bachelor’s degree in Materials Science, Chemistry, Biomedical Engineering, or related technical field; advanced degree is an advantage
• Substantial experience in materials management, data documentation, or regulatory support, ideally in the medical device or pharmaceutical industry
• Familiarity with ISO 10993, ISO 14971, EU MDR, FDA, and other relevant regulations related to material safety and compliance
• Understanding of polymers, metals, adhesives, coatings, and their relevance for biocompatibility and regulatory submissions
• Strong ability to organize, structure, and maintain material databases with high accuracy and traceability
• Experience in requesting, reviewing, and clarifying material declarations, certificates, and compliance documentation
• Ability to evaluate technical material data critically and translate into actionable information for biocompatibility assessments
• Clear written and verbal skills to interact with cross-functional teams (R&D, Regulatory, Biocompatibility, Purchasing, QA)

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