Research and Development
(Senior) Toxicological Expert (m/f/d)
Address:
Job ID: R0234950
Location Type: Hybrid
Research and Development
Address:
Job ID: R0234950
Location Type: Hybrid
As a Clinic Manager at Fresenius Medical Care, you’ll manage the daily operations of our outpatient centers. More importantly, you’ll be the key driver in carrying out our mission: To deliver superior care that improves the quality of life of every patient, every day, setting the standard by which others in the health care industry are judged. This is accomplished by hiring, developing and inspiring a multi-disciplinary team, collaborating with physicians, tracking and delivering superior patient outcomes and monitoring regulatory and safety requirements. Strong management skills are required and prior direct patient care experience is needed for occasions when the team needs a helping hand.
Patient Care Technicians (PCTs) at Fresenius Medical Care support and collaborate with RNs to provide dialysis treatment to several patients at a time while maintaining the functionality of the clinic. This involves prepping and testing equipment, reviewing treatment sheets, and opening the clinic at 4am for first shift. PCTs have a combination of technical skills and genuine passion needed to develop deep relationships with patients and improve their quality of life. Qualified candidates have prior customer service, healthcare and direct patient care experience, and will have the opportunity to learn the discipline of dialysis.
Fresenius Medical Care nurses are on the front line of patient care, improving the quality of life of every patient, every day. That means providing dialysis care to 10-12 patients at any given time, and collaborating with our multi-disciplinary team to deliver a unique care plan to each one of them. This role is all about relationships and the bond you’ll create with patients and their families. Prior dialysis nursing experience is helpful, but many successful candidates come from a background in ICU, PCU and/or surgery.
Inpatient RNs at Fresenius Medical Care perform dialysis treatments on an acute patient population in a hospital setting, including ICU, ER, Rehab, and Med/Surg units. What makes this role truly unique is the level of autonomy you’ll enjoy. Inpatient nurses are specifically accountable for administering and assessing each patient’s treatment plan. And because dialysis is a critical treatment for many hospital procedures and health conditions, you’ll have the opportunity to work with a wide variety of patients. Ideal candidates possess leadership skills and independence needed to make quick decisions in a fast-paced environment. Must be capable of educating patients and providing exceptional customer service to our partners. Six months to one year of dialysis experience or some form of critical care nursing experience are also required.
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 125,000 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!
In your role as (Senior) Toxicological Expert (m/f/d), you will be responsible for toxicological evaluations and risk assessments of medical devices in compliance with MDR (EU 2017/745), ISO 10993-17, and related regulatory guidelines.
Derive strategy for toxicological evaluations and risk assessment acc. ISO 10993-17 for different product groups and therapies
Support biocompatibility strategy details including material characterization, sampling of different product groups, chemical-analytical and biological testing as well as overall evaluation
Analyze results of chemical-analytical and biological testing for their toxicological profiles
Create toxicological risk assessments for leachables and extractables studies for all relevant products
Perform toxicological evaluations of substances or if needed assignment of mandates for external toxicologists and review of respective assessments
Support and coordinate with projects and product responsibles how to interpret the findings and measures to be taken, e.g., change of materials or production processes, measures to minimize leachables, etc.
Revise existing toxicological risk evaluations or reports for substances to comply with state-of-the-art data
Drive the global exchange and knowledge increase wrt toxicological evaluation of relevant substance groups and respective measures
Support with toxicological expert know-how and contribute to the overall biocompatibility reports for the products
Successfully completed master’s degree in scientific or engineering or a similar technical field required, such as medical technology
Related working experience: 2–8 years, depending on level (Expert / Senior Expert)
Advanced training in toxicology, e.g., avocational studies, trainings, etc.
Certification as toxicologist or started education highly welcome, e.g., European Registered Toxicologist (ERT) or Board Certified Toxicologist (DABT).
Deep knowledge of ISO 10993 standard series including respective trainings
Significant experience in chemical-analytical as well as biological biocompatibility testing as well as evaluations
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
What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.
What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.
What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.
What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.
“I successfully completed the RN program and went on to hold the position of Staff RN, Charge Nurse, and finally Clinical Manager.”
“Every day I walk in I am changing lives for the better and working to inspire my patients.”
“I am a member of an outstanding team that helps patients gain more control, achieve tangible goals, and live better lives.”
“My goal is to make sure that our patients keep their mobility and quality of life. This goal is really personal for me. My own father always had really bad vasculature in his leg and never had access to the kind of care we offer — eventually he lost blood flow and mobility. Knowing what he went through makes me even more committed to our mission.”
We fully believe that dedication and passion should be recognized and rewarded. That’s why we offer a competitive compensation and benefits package to all of our employees. Our benefits provide the flexibility, choice and support you need to be at your best as you play a vital part in helping patients live longer, better and healthier lives.
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