Aktuelle Jobs im Zusammenhang mit Expert Material Compliance, Biocompatibility - Bad Homburg vor der Höhe - Fresenius Medical Care


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  • Bad Homburg vor der Höhe, Hessen, Deutschland Taunus Sparkasse Vollzeit

    Trainee ComplianceWir suchen einen Trainee Compliance, der sich in unserem Team einbringen möchte und sich für die Themen Compliance und Risikomanagement begeistert.Als Trainee Compliance werden Sie Teil eines vielseitigen Teams aus Expertinnen und Experten mit unterschiedlichsten Fähigkeiten. Sie werden in anspruchsvolle und spannende Aufgaben...

Expert Material Compliance, Biocompatibility

vor 4 Monaten


Bad Homburg vor der Höhe, Deutschland Fresenius Medical Care Vollzeit

Über uns
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 and be a vital part of our team. #careerswithapurpose at Fresenius Over 128,000 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. 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. Main tasks: Material compliance: Evaluation of raw materials as well as finished products concerning regulatory EHS-requirements on substances and materials (REACH, POP, MDR, CLP, Packaging Directive etc.) Contact person to external supplier concerning the before mentioned requirements Creation and maintenance of dossiers for Nordic eco labeling (Nordic Swan) Support Registration / Regulatory Affairs and Product Center with required information regarding material compliance, e.g. Tender requests Value Stream and Development support activities: Expert within cross-functional teams concerning EHS material compliance and biocompatibility questions Support in second source and material change projects Biocompatibility / Toxicology: Support Development of biocompatibility evaluation strategies 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 (Inhalt entfernt) Biocompatibility Evaluations and Toxicological Expert statements Providing expert advice (e.g. expert statements) Acting as sponsor, study monitor and contact for chemical / biocompatibility studies in internal and external laboratories (creation of test plans and test reports) Compilation of overall biological safety assessment according to ISO (Inhalt entfernt) Secondary Tasks: Support regulatory compliance, speed 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 sub-teams) Support a Design Control approach and provide expertise to Value Streams and Q&R for compliance with applicable regulations (EU directive, local countries regulations) Close Collaboration regional as well as plant EHS departments and the central biocompatibility group Support Sustainability activities and internal and external audits Your profile: Scientific background (Masters degree) in Toxicology, Chemistry, Biology or Material Sciences or related fields Strong background in chemistry of medical polymers and materials used in contact with blood and the related analytical methods High identification with and loyalty to the department and the company 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 cross-functional with all levels of employees Organizational capacity and analytical ability Autonomy in decision-making Ability for a cross-functional coordination General knowledge of medical device risk management and related regulations General knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 2017/745, MDSAP etc.) General knowledge of applicable standards (e.g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CFR § 820.250, etc.) Knowledge of internal and external processes and structures and of the (global) corporate Quality Management requirements Knowledge in statistical methods Experience in scientific writing English (fluent, very good knowledge) Required: Office (Excel / Word / PowerPoint, Outlook, Teams) Knowledge Additional: SAP, PDM systems as PTC Windchill, FMEA tools Knowledge of Medical Device field and application, Dialysis and related therapies Independent working structure, hands on and ‘can do’ mentality Attitude to Team Work, ability to work in matrix environment Global mindset approach Your contact Fresenius Medical Care Deutschland GmbH Reference number R0150814 freseniusmedicalcare.com jobs.freseniusmedicalcare.com 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).

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