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

KARL STORZ; Tuttlingen; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading medical device company in Tuttlingen is seeking a Materials Manager to oversee data management, ensure regulatory compliance, and support biocompatibility evaluations. The ideal candidate will have a relevant degree and substantial experience in materials management, especially within the medical sector. This role offers flexible working options and numerous benefits including training and health management.

Leistungen

Flexible working hours

30 vacation days

Further training opportunities

Corporate benefits

Childcare options

Qualifikationen

• Substantial experience in materials management, ideally in the medical device or pharmaceutical industry.
• Familiarity with ISO 10993, EU MDR, FDA regulations.

Aufgaben

• Manage and maintain material data in databases and systems.
• Ensure regulatory compliance with global requirements.
• Support biocompatibility assessments with accurate material data.

Kenntnisse

Materials management

Data documentation

Regulatory support

Technical material evaluation

Ausbildung

Bachelor's degree in Materials Science or related field

Advanced degree

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 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