About this role
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
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