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Address:
- Else-Kröner-Str. 1, Bad Homburg, HE 61352, Germany
- al. Solidarności 36, Poznań, Województwo wielkopolskie 61-696, Poland
- Defense Depot Of Ogden, Ogden, UT 84404, United States of America
- Frankfurter Str. 6-8, St. Wendel, SL 66606, Germany
- Magnesitstraße 9, Krems, Niederösterreich 3500, Austria
- ZI PONCHONNIERE, L'ARBRESLE, Auvergne-Rhône-Alpes 69210, France
Job ID: R0275176
Location Type: Hybrid
Job Overview
Fresenius Medical Care serves around 292,000 dialysis patients worldwide and provides products in more than 140 countries. We are a vertically integrated medical technology (MedTech) and healthcare service company made up of three operating segments: Care Delivery, Value-Based Care, and Care Enablement. This structure allows us to provide the full spectrum of healthcare services, systems, devices, technologies, products, and pharmaceuticals to deliver high-quality care to people living with kidney disease.
Job Description
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 vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 110,000 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 Care’s 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!
Your Purpose
As Director of the Global Biocompatibility and Toxicology Competence Center, you will be responsible for establishing and leading a globally aligned, high-performing team of experts. Your mission is to define and implement FME’s overarching biocompatibility strategy across medical devices and primary packaging materials, ensuring regulatory compliance and product safety in line with the highest standards of patient care.
Your tasks:
- Build, lead, and develop the Global Biocompatibility and Toxicology Competence Center, both professionally and disciplinary.
- Derive overarching biocompatibility strategy for all relevant products of Care Enablement, i.e., medical devices and primary packaging materials for drugs.
- Process-owner for biocompatibility SOP package within FME’s QMS.
- Strong involvement and integration in development and sustaining projects with the team’s expertise.
- Professional and transparent resource management and prioritization of tasks
- Derive an overarching strategy biocomp strategy (sampling, testing, evaluation etc.) with all verticals.
- Align sampling and testing strategies and support product responsibles/product development groups to apply them.
- Qualification of test laboratories and subsequent alignment of requirements for studies, e.g., AET, test methods, etc.
- Support evaluation of analytical and biological results gained by internal or external testing labs.
- Oversee the creation of biocomp files including BEP (biological evaluation plant), BER (biological evaluation report) TRA (toxicological risk evaluation) and risk assessments.
- Agree strategy with regulatory agencies and notified bodies.
- Actively work in standard committees and create network to agencies and experts in the field of biocompatibility.
- Manage interfaces and stakeholder relations with R&D teams within CE Verticals, incl. communication of global biocompatibility and toxicology strategy and priorities.
Your profile:
- 7–10 years of hands-on experience in the biocompatibility evaluation of medical devices and/or drug packaging materials
- Sound expertise in biocompatibility testing methodologies; laboratory management experience is a strong asset
- In-depth knowledge of the ISO 10993 series; relevant certifications and training preferred
- Knowledge in toxicology and risk management is a plus
- Strong leadership experience in an international context and matrix environment, supporting and fostering performance culture and individual and team accountability
- Strategic and visionary personality able to balance short-term priorities and long-term vision
- Excellent project management and organizational skills; structured and detail oriented.
- Strong communication and stakeholder management skills; capable of handling complex topics with clarity and confidence
- Advanced experience with PTC Windchill PDM; working knowledge of Polarion ALM is a plus
- Proficient in Microsoft Office and related business tools
- Committed to continuous learning and able to thrive in a dynamic environment.
- Fluent in business English; additional languages (e.g., German, French, Italian) are a plus
Our offer for you:
There is a lot you can discover at Fresenius Medical Care because we have a lot to offer. No matter what field you are an expert in and how much experience you have - for your professional future with meaning:
- The opportunity to work in a hybrid model
- Whether in front of or behind the scenes - you will help to make better medicine accessible 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
We are committed to diversity and equal opportunities and welcome applications from people with disabilities.
Care in every moment. Connection in every step.
Our Offerings
We are committed to your total well-being.
We want to help you thrive and are committed to an equitable workplace that fuels individual success and our company's growth. With tailored healthcare, wellness programs, training, and consistent support, our programs ensure you have the resources to be your best self at work and at home.
Health
Wealth
Well-being
Development
Health
- Medical plan options
- Dental insurance
- Vision plan
- Short- and long-term disability
Wealth
- 401(k) retirement plan with company match
- Student debt and loan support
- Flexible spending accounts
- Commuter benefits
- Employee discounts
Well-being
- Hybrid working model
- Paid time off and leave programs
- Fertility, family building, and postpartum support
- Caregiving support
Development
- Go4RN program helps employees get to RN status with covered tuition and eligible expenses
- Tuition assistance for employees and their families
- Digital access to high-quality educational content, through The University, for all employees worldwide
* For more information and eligibility requirements, please contact your recruiter or HR representative.
Important notices Fraud Notice
Fresenius Medical Care is aware of fraudulent communications from individuals or organizations falsely claiming to represent our company. To help protect yourself, please note:
- Fresenius Medical Care will only contact candidates using official company email domains or through Cara, our virtual AI (Artificial Intelligence) assistant at Fresenius Medical Care.
- We do not request payment, fees, gift cards, cryptocurrency, or banking information at any stage of the recruitment process.
- We do not conduct interviews exclusively through messaging apps or social media platforms.
- All legitimate job openings are posted on our official careers website.
If you receive suspicious communication claiming to be from Fresenius Medical Care, do not respond or share personal information. We encourage you to report the activity to your local consumer protection agency, law enforcement authority, or cybercrime reporting center. We have included links for the most common hiring locations for your convenience.
- United States: Federal Bureau of Investigation (IC3) – www.ic3.gov
- Germany: Bundeskriminalamt (BKA) – www.bka.de
- United Kingdom: Action Fraud – www.actionfraud.police.uk
- Poland: CERT Polska – www.cert.pl
- India: National Cyber Crime Portal – www.cybercrime.gov.in
- Mexico: Guardia Nacional – www.gob.mx/gn
- Philippines: Philippine National Police Anti-Cybercrime Group – www.pnp.gov.ph
We are committed to maintaining a safe and transparent recruitment process.
Recruitment Agency
If you are a recruitment agency submitting a resume on behalf of a client: Fresenius Medical Care AG and its affiliates (FME) only accepts candidate submissions from agencies on its approved Preferred Supplier List. All third-party searches and submissions require an existing signed agreement and prior, written approval from Human Resources; all other submissions will be considered unsolicited. Do not forward resumes or candidate information without such authorization to our applicant tracking system, any company email address, and/or any FME employee, including FME Management. FME disclaims any liability for any fees, commissions, or other charges associated with unsolicited submissions.
EEO is the Law
- View the EEO Policy Statement here (PDF).
Accommodation Requests
If you have a disability and need a reasonable accommodation in order to search for a job opening or to submit an online application, please contact Fresenius Medical Care Accommodations Team or call toll-free 855.362.6247.
Vollzeit
Sonstige im Bereich Wirtschaftsingenieurwesen
