Senior Biocompatibility Specialist (m/f/d)

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