(Junior) Material Data Specialist (m/f/d)

KARL STORZ; Tuttlingen; Hybrid; EUR 45.000 - 60.000; Vollzeit

Zusammenfassung

A medical technology company in Tuttlingen is looking for a materials data expert to manage and maintain compliance documentation. Responsibilities include coordinating with suppliers and ensuring alignment with global regulations while supporting biocompatibility evaluations. Candidates should have a strong background in materials science and data management with experience in regulatory support. The role offers flexible working hours, 30 vacation days, and other benefits.

Leistungen

Flexible working hours

30 vacation days

Further training opportunities

Corporate benefits

Pension plan subsidy

Childcare options

Qualifikationen

• Substantial experience in materials data management, ideally in the medical device or pharmaceutical industry.
• Familiarity with ISO 10993, EU MDR, FDA regulations related to material safety.
• Strong organizational skills to maintain material databases.

Aufgaben

• Manage and maintain material data for compliance and evaluation.
• Support regulatory compliance with accuracy in documentation.
• Coordinate with suppliers for material declarations and certificates.

Kenntnisse

Materials data management

Regulatory support

Technical evaluation

Cross-functional communication

Ausbildung

Bachelor’s degree in Materials Science, Chemistry, Biomedical Engineering or related field

Tools

Microsoft Excel

Jobbeschreibung

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 data 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 in Microsoft Excel
• 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