Job Description

Job Function: Research & Development
Location:
Tuttlingen, BW, DE, 78532
Work Location (for field-based positions):
Work Flexibility: Hybrid
Job ID: 4748
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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
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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)
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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

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Carsten Engel | Recruiter Talent Acquisition
Carsten.Engel@karlstorz.com
4748