Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases. As a global health care company, we have a special goal: provide the best possible care. Join us to improve the quality of life for a growing number of patients around the world andbe a vital part of our team....+ ← Bad Homburg / Hessen · Permanent · Full-time · As of now Material Compliance, Biocompatibility & Toxicological Expert (m/f/d) In your role as Material Compliance, Biocompatibility & Toxicological Expert (m/f/d) you will be responsible for biocompatibility evaluation of medical devices according to the Regulation (EU) / on medical devices (MDR), ISO -series and other regulatory guidelines / requirements and to ensure documentation of EHS compliance of FME’s product portfolio. Your assignments * 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 -17) * Providing expert advice (e.g. author of expert statements) * Acting as sponsor, study monitor and contact for chemical/biocompatibility studies in internal and external laboratories (creation of test plans, test protocols, review, and approval of test reports) * Compilation of overall biological safety assessment according to ISO -1 * Evaluation of raw materials as well as finished products concerning regulatory EHS-requirements on substances and materials (REACH, POP, MDR, CLP, Packaging etc.) * Contact person to external suppliers concerning the before mentioned requirements * Support regulatory affairs and value stream interfaces with required information regarding material compliance, e.g. tender requests * Support development of biocompatibility evaluation strategies * Support regulatory compliance, speed up time to market, reduction of risks to patients resulting in an increase in overall user satisfaction and enhanced regulatory compliance (as member of CFT or extended subteams) * Collaborate with engineering teams from the early stages of development to provide quality assurance input and support * Expert within cross-functional teams concerning EHS material compliance and biocompatibility questions * Support in second source and material change projects Your profile * Successfully completed scientific background (master’s degree) in toxicology, chemistry, biology, or related fields * First years of experience in regulatory affairs or quality environment in pharmaceutical / medical device field * Biocompatibility evaluations and toxicological expert statement (related to the ISO series) * Strong background in chemistry of medical polymers and materials used in contact with blood and the related analytical methods * Advanced knowledge of medical device risk management and related regulations * Advanced knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR /, MDSAP etc.) * Advanced knowledge of applicable standards (e.g. ISO, ISO, ICH Q10, EU GMP, FDA 21 CFR § .1, etc.) * Knowledge of internal and external processes and structures and of the (global) corporate quality management requirements * Good and professional relationship to and communication with international colleagues and superiors * High engagement on achieving the targets and on the objectives of the position, proactive and solution-oriented approach towards problems, ability to work independently as well as within the cross-functional team * Fluent in English, in written and spoken, and a good knowledge of German Apply now Share this job Print this Page Your contact Fresenius Medical Care Deutschland GmbH Reference number R At a glance Career level: Experienced Professionals Job category: Medical Engineering Working condition: Full time Business segment: Fresenius Medical Care Location: Bad Homburg / Hessen Closing date for application: none – We are looking forward to your application More information Information about the application process Our offer at a glance “The questions that take top priority in our work are how to best listen to our patients' voice, recognize their needs and gear our processes towards them. It's a very fulfilling role.“ Sandra Löber Program Manager Medical Sustainability, Fresenius Medical Care Fresenius Medical Care – Creating a future worth living. For patients. Worldwide. Every day. More than four decades of experience in dialysis, innovative research, the global leader in dialysis services and products – that is Fresenius Medical Care. We welcome diversity At Fresenius Medical Care all job applicants are welcome – regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics. All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse). #careerswithapurpose at Fresenius Over, people across the globe work at Fresenius to provide better ever medicine for ever more people. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.