At Fresenius Medical Care we are the global leader in kidney care committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality innovative products services and care across the entire healthcare journey. Guided by our visionCreating a future worth living. For patients. Worldwide. Every work with purpose and compassion supported by a global team of over 125000 employees.

Within our Care Enablement segment we develop and provide life-sustaining medical products digital health solutions and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation efficiency and sustainable growth.

Our values guide how we work:

• We Care for our patients each other and our communities

• We Connect across teams and borders to deliver excellence together

• We Commit to doing things the right way growing with purpose and leading kidney care with integrity and innovation

Systems Quality & Regulatory (SQR) a global function within Care Enablement ensuring Fresenius Medical Cares products meet the highest standards of quality safety and regulatory compliance throughout the entire product lifecycle. The team supports market access innovation and patient safety by driving excellence across manufacturing and supply chain overseeing post-market surveillance and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations. Join our passionate team and help shape healthcare worldwide!

In your roleas(Senior) Expert Biocompatibility(m/f/d) you willbe responsible forbiocompatibilityevaluation of medical devices in the framework of Regulation (EU) 2017/745 on medical devices (MDR) ISO 10993-seriesand other regulatory guidelines/requirements.

Yourtasks

• Performance of safety and risk assessments for medical devicesbasedon the used raw materials on extractable and leachable chemicals or onbiocompatibilitystudies (ISO 10993series)

• Planninginterpretationand evaluationof analyticaland biological testsperformedby internal or external laboratories

• Compilation of overall biological safety assessment according to ISO 10993-1

• Derive biocompatibility strategy details including material characterization sampling of different product groups during new product developments or material/product changes

• Acting as sponsor studymonitorand contact for chemical/ biocompatibility studies in internal and externallaboratories

• Ensure sufficient support ofbiocompatibilityprojects and coordinate how to apply overarching strategies

• Align sampling and testing strategies and support productresponsibleshow to apply these

• Coordinate global alignment of laboratory partners (internal and external) as well as methods applied

• Overall responsibility for theassignedproduct groups and relatedbiocompatibility files

• Contribute to supplier agreements and specifications for biocompatibility requirements as well as materialselection

• Observe upcoming regulation changes and ensuretimelyimplementation considering state-of-the artmethodology

Yourprofile

• Successfully completed mastersdegree in scientific or engineering or a similar technical fieldrequired such as medical technology

• Related working experience: 28 years depending on level (Expert / Senior Expert)

• HighlyExperiencedin writing biocompatibility evaluations

• DeepKnowledge withbiocompatibility-testingand evaluationsofmedicaldevices according to ISO 10993

• Application of Design Control and Risk Management and knowledge and familiarity with the concepts of FDA CFR 820 ISO13485 and ISO 14971

• StrongKnowledge with medical device risk managementprocessand related regulations

• Experience with product or design and development or quality engineering of sterile disposablesutilizingvarious plastic processes such as injection molding and extruding

• Ability to communicate technical information to non-technical audiences

• Familiar with agilemethodology

• Proventrack recordinproject and/ortestmanagement

• Proficientwith ALMand PDMsystems

• Familiar with durablesand disposablesof medical devices

• Fluent in German and English both written and spoken

• Willingness to travel on an average monthly cadenceand to work in different time zones

Our Offer for you

There is a lot you can discover at Fresenius Medical Care regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.

• Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world

• Individual opportunities for self-determined career planning and professional development

• A corporate culture in which there is enough room for innovative thinking - to find the best solution together not the quickest one

• A large number of committed people with a wide range of skills talents and experience

• The benefits of a successful global corporation with the collegial culture of a medium-sized company