Senior Biocompatibility Specialist (m/f/d)

Karl Storz; Neuhausen ob Eck; Hybrid; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Hybrid work model

Health, dental or medical coverage

30 vacation days

Employee training programs

Pension plan subsidy

Job summary

KARL STORZ in Neuhausen ob Eck is seeking a Senior Biocompatibility Specialist to assess biocompatibility, support testing, and aid in regulatory approvals for medical devices. The role emphasizes adherence to global standards and collaboration across R&D, Production and Regulatory Affairs.

Required is a university degree in toxicology/chemistry/materials science or related field, strong English, and a solid understanding of ISO 10993 and regulatory frameworks.

Qualifications

• Knowledge of biocompatibility and toxicology for medical devices.
• Familiarity with regulatory requirements and international standards (ISO 10993).
• Experience planning, evaluating or documenting biocompatibility/toxicity testing.
• Additional training in biocompatibility or toxicology is desirable.

Responsibilities

• Assess biocompatibility: identify regulatory requirements for new products/materials.
• Support biocompatibility and toxicity testing with related documentation.
• Perform preclinical product safety assessments per international standards.
• Contribute technical expertise to regulatory approvals of products.
• Advise on regulatory requirements for biocompatibility/toxicology across the global organization.
• Ensure compliance with standards and guidelines for sterile single-use endoscopes.
• Support compliance with QMS and international regulatory requirements (ISO 13485, US CFR, Canadian MDR).
• Collaborate with R&D, Product Management, Production and Regulatory Affairs.

Skills

Biocompatibility knowledge

Regulatory understanding

English communication

Quality mindset

Cross-functional collaboration

Documentation skills

Regulatory strategy

Education

University degree in toxicology/chemistry/materials science/process engineering

Job description

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At KARL STORZ, we take pride in helping patients
through some of the toughest journeys of their lives.
We are making contributions that matter.
Regardless of your role, YOU improve patients’ lives every day.

Get to know us and join our teamas

Senior Biocompatibility Specialist (m/f/d)

Job Function: Research & Development

Location: Neuhausen ob Eck, BW, DE, 78579

Work Location (for field-based positions):

Work Flexibility: Hybrid

Job ID: 6039

Your Mission

• Assess biocompatibility: Identify regulatory requirements and assess new products and materials with regard to their biocompatibility.
• Support biocompatibility and toxicity testing: Prepare and support biocompatibility and toxicity testing, including the related documentation.
• Ensure preclinical product safety: Conduct preclinical product safety assessments for our products at various levels in accordance with international standards.
• Support product approvals: Contribute your technical expertise to support the regulatory approval of our products.
• Implement regulatory requirements: Advise and support our global organization in complying with regulatory requirements related to biocompatibility and toxicology.
• Ensure compliance with international standards: Ensure compliance with current international standards and guidelines for sterile single-use endoscopes with regard to biocompatibility and toxicology.
• Meet quality requirements: Support compliance with our QMS and corporate requirements as well as relevant international regulatory requirements, particularly ISO 13485, the U.S. Code of Federal Regulations and the Canadian Medical Device Regulations.
• Collaborate across functions: Work closely and effectively with colleagues from R&D, Product Management, Production and Regulatory Affairs.

Your Talents

• University degree in toxicology, chemistry, materials science, process engineering or a comparable field
• Basic knowledge of biocompatibility and toxicology related to medical devices
• Knowledge of relevant regulatory requirements and international standards for the biological evaluation of medical devices, particularly the ISO 10993 series
• Knowledge of the planning, evaluation or documentation of biocompatibility and toxicity testing
• Additional training in biocompatibility or toxicology is desirable
• Technical understanding of medical devices and the ability to quickly familiarize yourself with different products and materials
• Strong quality awareness, sense of responsibility and a structured approach to work
• Very good English skills for working in an international environment
• 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