other
Added 2 weeks ago(Senior) Biocompatibility & Toxicological Expert (m/f/d)
at NextStage
Bad Homburg, He, United StatesOn-site
Requirements
- Experience in project management or cross-functional coordination Strong knowledge of medical device regulations and standards (e.g.
- MDR 2017/745, ISO 13485, ISO 14971, ISO 10993 series, FDA 21 CFR Part 820).
- Good understanding of global quality management systems and regulatory environments Strong analytical skills, structured working style, and
- experience in scientific writing; knowledge of statistical methods is a plus Ability to work independently and lead cross-functional topics without direct disciplinary authority Proactive, solution-oriented mindset with strong organizational and communication skills
- Experience collaborating in international environments Fluent in English and German/Italian written and spoken Proficient in MS Office and familiar with relevant systems (e.g.
- TrackWise/QTRAK, Windchill, FMEA tools)
- Experience in the medical device field; exposure to dialysis or related therapies is an advantage Team-oriented mindset, global perspective, and ability to collaborate across corporate functions 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.
Benefits
- 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.
- 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 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.