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

KARL STORZ SE & Co. KG; Tuttlingen; Hybrid; EUR 50.000 - 65.000; Vollzeit

Zusammenfassung

A leading medical device company in Tuttlingen is seeking a (Junior) Material Data Specialist to manage material data and ensure regulatory compliance. The ideal candidate will have a Bachelor's degree in a relevant field and experience in materials data management, ideally in the medical device industry. This role offers hybrid work flexibility, competitive leave, and training opportunities.

Leistungen

30 vacation days

Further training opportunities

Health, sports, cultural and leisure activities

Qualifikationen

• Bachelor's degree in a relevant technical field required.
• Substantial experience in materials data management preferable.
• Familiarity with ISO 10993 and related regulations helpful.

Aufgaben

• Manage and maintain material data within dedicated databases.
• Support biological evaluation by providing accurate material data.
• Ensure compliance with global regulatory requirements.

Kenntnisse

Material data management

Regulatory compliance

Data documentation

Critical evaluation

Organizational skills

Communication skills

Ausbildung

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

Advanced degree

Tools

Microsoft Excel

Jobbeschreibung

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

Job Function: Research & Development

Location: Tuttlingen, BW, DE, 78532

Work Location (for field-based positions):

Work Flexibility: Hybrid

Job ID: 4748

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)
• 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

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