Biocompatibility & Toxicological Expert (m/f/d)
In your role as Biocompatibility & Toxicological Expert (m/f/d)you will bepartner to product development teams to ensure compliant and safe products regarding biocompatibility & toxicological, engineering teams are supported with a value-added mindset.
Your tasks
- Biocompatibility evaluation of medical devices in the framework of Regulation (EU) 2017/745 on medical devices (MDR), ISO 10993-series and other regulatory guidelines/requirements
- Define biocompatibility evaluation strategies for design & development projects
- Expert within cross functional teams concerning material compliance and biocompatibility questions
- Performance of safety and risk assessments for medical devices, based on the used raw materials, on extractable and leachable chemicals or on biocompatibility studies (ISO 10993-17)
- Providing expert advice
- Acting as sponsor, study monitor, and contact for chemical/biocompatibility studies in internal and external laboratories
- Compilation of overall biological safety assessment according to ISO 10993-1
Your profile
- Successfully completed bachelor’s or master’s degree in scientific or engineering or a similar technical field required, such as medical technology
- Several years related experience or an advanced degree without experience or equivalent directly related work experience
- Experience in writing biocompatibility evaluations and toxicological expert statements
- Application of Design Control and Risk Management and knowledge and familiarity with the concepts of FDA CFR 820, ISO13485, IEC 60601 and ISO 14971
- Knowledge with medical device risk management and related regulations
- Knowledge with biocompatibility-testing of Medical Devices according to ISO 10993
- Ability to communicate technical information to non-technical audience
- Very good presentation and communication skills
- Fluent in German and English, in written and spoken
Career with a purpose
Inclusion and diversity
Stability
Learning and development
Local benefits
Work-life balance
At a glance
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Develop new, tailored solutions for dialysis patients
About 3.5 million patients worldwide depend on regular dialysis treatment. Fresenius Medical Care is committed to enabling a future worth living for these people. Our teams in Research and Development, operating in 23 locations across three regions, are responsible for the ongoing development of the medical products and treatments required across the renal care spectrum.
We drive research on innovative dialysis devices and turn it into reality. To deliver solutions that are continuously optimized and tailored to meet patients’ specific needs, we develop IoT-supported diagnostic methods and evidence-based, individualized treatments. Our integrated, multidisciplinary approach to research and development speaks to specialists as well as generalists.
Deliver technical excellence on a global scale
Discover the benefits of joining a global organization that is committed to excellence and quality. We support your career journey by helping you fulfill your ambitions. That’s how we create value for our patients and our employees.
As market leader, Fresenius Medical Care sets new, higher standards in dialysis. Help us define them: become part of a talented team that drives innovation in health care. Join our scientists and professionals in delivering excellence on a global scale.
We care about sharing information and experiences as this helps us learn from our mistakes and each other. We tackle challenges together by reaching out to colleagues both near and far. We communicate openly.
We challenge the status quo and show interest in what happens around us. We ask questions to clearly understand what needs to be done and take ownership of the results.
We live up to our own expectations, show respect and lead by example. We act with integrity and in line with our standards every day.
We make things better today than they were yesterday. We pitch ideas on how to improve and innovate.
What we stand for
Empowering people. Advancing care. Inspiring with our purpose and values.
Everything we do here is about making people’s lives better, simpler and longer. Our teams work cross-functionally to reproduce the complex function of kidneys with treatments that meet high quality standards, improve clinical outcomes, and are sustainable and compliant. Internally, we promote diversity and inclusion as key elements of a positive, supportive work environment. Our values support our mission to develop high quality products and services, to have a positive impact on the health and wellbeing of patients, and to lead Fresenius Medical Care towards a successful, sustainable future.