Biological Evaluation Specialist
vor 4 Wochen
At HARTMANN, we're committed to helping healthcare professionals focus on what matters most: positively impacting people's lives. We realize solutions that make a difference, and with your expertise, you can grow on your job every day. As a Biological Evaluation Specialist, you'll support our efforts in ensuring the safety of medical devices. Your responsibilities will include interpreting ISO 10993 requirements, developing biological evaluation strategies, and collaborating with external labs and toxicologists to ensure compliance with industry standards. You'll also represent our business division in working groups, maintain key relationships with testing institutes, and support cross-functional teams to ensure the highest safety standards for our products.
Key responsibilities include:
- Interpreting ISO 10993 requirements and evaluating outcomes considering device factors, intended use, and scientific knowledge
- Creating biological evaluation plans/reports and coordinating biological testing with external labs and toxicologists
- Supporting the development of biological strategy
- Assisting representatives of the Business Division and HARTMANN in working groups related to changes in legislation or standards
- Establishing and maintaining contacts with testing institutes and external service providers
- Collaborating with departments like R&D, Manufacturing Engineering, and Procurement to ensure biological evaluations comply with EN ISO 10993
- Assessing biocompatibility of materials, supporting product registration, and contributing to risk analysis and clinical evaluation reviews
Qualifications include:
- Degree in natural science, life science, or engineering
- Knowledge in scientific and/or clinical working (e.g., chemical, microbiological, or quality lab)
- Knowledge in the field of medical devices, regulatory affairs, or quality management desired
- Willingness to learn about new technologies and materials
- Analytical, organizational, and communication skills
- Fluency in German and English
Benefits include:
- Flexible working conditions, such as flexible working hours and mobile working
- Attractive ways of combining work and family life, e.g., childcare subsidy
- 30 days paid leave per year, plus special leave for exceptional life events, as well as vacation pay and special annual payment according to collective agreement
- Company pension plan with attractive employer contribution, including matching model for deferred compensation
- Plenty of parking spaces, canteen with café bar, and ongoing offers in the employee shop
- Access to over 6,000 fitness and yoga studios, swimming pools, as well as Crossfit and bouldering halls (EGYM Wellpass)
- Various health and fitness offers, e.g., skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break, etc.
- Job Bike Leasing
- Attractive discounts on e.g., travel, fashion, and technology via our corporate benefits platform
Shape a career that's focused on healthcare customers, fit for the future, and grounded in a culture of trust and openness. Apply now via our online platform.
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