Aktuelle Jobs im Zusammenhang mit Expert Material Compliance, Biocompatibility - Bad Homburg vor der Höhe - Fresenius Medical Care
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Biocompatibility Analyst II
vor 1 Monat
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitPOSITION SUMMARY: The Biocompatibility Engineer II plays a crucial role in the evaluation and development of medical products, focusing on biocompatibility and toxicological assessments. This position involves collaborating with cross-functional teams to ensure compliance with regulatory standards and to support the innovation of Fresenius Medical Care...
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Senior Biocompatibility Engineer
vor 1 Monat
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitPOSITION SUMMARY: The Biocompatibility Engineer II plays a crucial role in the evaluation and development of products at Fresenius Medical Care. This position involves participating in design initiatives, assessing prototypes, and engaging in research and development activities to ensure biocompatibility and address toxicological as well as environmental...
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Biocompatibility Evaluation Engineer II
vor 1 Monat
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitPOSITION SUMMARY: The Biocompatibility Engineer II plays a crucial role in the evaluation and development of medical products, ensuring they meet the necessary biocompatibility and safety standards. This position involves participating in design projects, assessing prototypes, and collaborating with research and development teams to address biocompatibility...
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Biocompatibility Assessment Engineer II
vor 1 Monat
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitPOSITION SUMMARY: The Biocompatibility Engineer II plays a crucial role in supporting design initiatives, evaluating prototypes, and engaging in research and development activities aimed at assessing biocompatibility and toxicological risks associated with products at Fresenius Medical Care. As part of the Quality & Regulatory team within the Vertical...
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Biocompatibility Specialist II
vor 1 Monat
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitPOSITION SUMMARY: The Biocompatibility Engineer II plays a crucial role in supporting design initiatives, conducting evaluations of prototypes, and engaging in research and development efforts to assess biocompatibility, toxicological aspects, and environmental health and safety (EHS) risks associated with Fresenius Medical Care products. As a key member of...
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Medical Device Compliance Expert
vor 3 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitAbout the RoleWe are seeking a highly skilled Medical Device Compliance Expert to join our team at Fresenius Medical Care. As a key member of our Regulatory Affairs department, you will be responsible for ensuring the compliance of our medical devices with relevant regulations.Key ResponsibilitiesDevelop and maintain technical documentation and regulatory...
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Expert Associate in Starting Materials Compliance
vor 4 Monaten
Bad Vilbel, Deutschland STADA Arzneimittel AG VollzeitHemofarm is a member of STADA Group, one of the largest global generic pharmaceutical companies, which successfully operates in both the markets of Serbia and Western Balkans. Hemofarm produces high quality pharmaceutical products within the leading pharmacotherapeutic groups, observing the key corporate values: Agility, Integrity, Entrepreneurship and ONE...
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Expert Associate in Starting Materials Compliance
vor 3 Monaten
Bad Vilbel, Deutschland STADA Arzneimittel AG Vollzeit**Hemofarm** is a member of STADA Group, one of the largest global generic pharmaceutical companies, which successfully operates in both the markets of Serbia and Western Balkans. Hemofarm produces high quality pharmaceutical products within the leading pharmacotherapeutic groups, observing the key corporate values: Agility, Integrity, Entrepreneurship and...
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Global Material Compliance Portfolio Manager
vor 2 Wochen
Bad Honnef, Nordrhein-Westfalen, Deutschland Hitachi Energy Ltd VollzeitJob SummaryHitachi Energy Ltd is seeking an experienced Material Compliance Portfolio Manager to lead the Transformer Business material compliance global portfolio strategy and related operations.About the RoleThis is a unique opportunity to work in an exciting global business and lead the material compliance global portfolio strategy and related...
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Global Material Compliance Portfolio Manager
vor 2 Wochen
Bad Honnef, Nordrhein-Westfalen, Deutschland Hitachi Energy Ltd VollzeitJob SummaryHitachi Energy Ltd is seeking an experienced Material Compliance Portfolio Manager to lead the Transformer Business material compliance global portfolio strategy and related operations.About the RoleThis is a unique opportunity to work in an exciting global business and lead the material compliance global portfolio strategy and related...
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Trainee Compliance Specialist
vor 6 Stunden
Bad Homburg vor der Höhe, Hessen, Deutschland Taunus Sparkasse VollzeitTrainee ComplianceWir suchen nach talentierten und engagierten Trainee-Compliance-Experten, die sich in unserem dynamischen Team einbringen möchten. Als Trainee-Compliance-Experte werden Sie Teil eines vielseitigen Teams aus Expertinnen und Experten mit unterschiedlichsten Fähigkeiten und unterstützen Sie Ihre Kolleginnen und Kollegen im operativen...
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Trainee Compliance Specialist
vor 6 Stunden
Bad Homburg vor der Höhe, Hessen, Deutschland Taunus Sparkasse VollzeitTrainee ComplianceWir suchen nach talentierten und engagierten Trainee-Compliance-Experten, die sich in unserem dynamischen Team einbringen möchten. Als Trainee-Compliance-Experte werden Sie Teil eines vielseitigen Teams aus Expertinnen und Experten mit unterschiedlichsten Fähigkeiten und unterstützen Sie Ihre Kolleginnen und Kollegen im operativen...
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Bad Honnef, Nordrhein-Westfalen, Deutschland Hitachi Energy Ltd VollzeitPosition: Global Compliance Manager for Material Strategies at Hitachi Energy TransformersAre you prepared to assume the role of Global Compliance Manager for Material Strategies within the Transformers division at Hitachi Energy? This position presents an exceptional opportunity to spearhead the global strategy for material compliance in a forward-thinking...
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Manager of Global Material Compliance Strategy
vor 1 Monat
Bad Honnef, Nordrhein-Westfalen, Deutschland Hitachi Energy Ltd VollzeitJob Title: Global Material Compliance Portfolio Manager at Hitachi Energy TransformersAre you prepared to assume the role of Global Material Compliance Portfolio Manager for Transformers at Hitachi Energy Transformers? This position presents an exceptional opportunity to spearhead the global strategy for material compliance within a forward-thinking and...
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Bad Honnef, Deutschland Hitachi Energy Ltd VollzeitDescription : Global Material Compliance Portfolio Manager, Transformers. Within the Hitachi Energy Transformers business, we are looking for an experienced Material Compliance Portfolio Manager. This newly created position is a unique opportunity to work in an exciting global business and lead the Transformer Business material compliance global...
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Global Compliance Manager for Material Standards
vor 1 Monat
Bad Honnef, Nordrhein-Westfalen, Deutschland Hitachi Energy Ltd VollzeitJob Title: Global Compliance Manager for Material Standards at Hitachi Energy Ltd.Are you prepared to assume the position of Global Compliance Manager for Material Standards at Hitachi Energy Ltd.? This role presents an exceptional opportunity to spearhead the global strategy for material compliance within a forward-thinking and vibrant international...
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Trainee Compliance Specialist
vor 8 Stunden
Bad Homburg vor der Höhe, Hessen, Deutschland Taunus Sparkasse VollzeitKARRIERE BEI DER TAUNUS SPARKASSEMitten im Rhein-Main-Gebiet befindet sich die Taunus Sparkasse, Ihr neuer Arbeitgeber. Wir sind ein starker Partner für Vereine sowie für soziale, kulturelle und sportliche Projekte. Unsere Mission ist es, Bürgerinnen und Bürger, Unternehmen und Kommunen unserer Region mit zuverlässigen Bankdienstleistungen zu...
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Trainee Compliance Specialist
vor 8 Stunden
Bad Homburg vor der Höhe, Hessen, Deutschland Taunus Sparkasse VollzeitKARRIERE BEI DER TAUNUS SPARKASSEMitten im Rhein-Main-Gebiet befindet sich die Taunus Sparkasse, Ihr neuer Arbeitgeber. Wir sind ein starker Partner für Vereine sowie für soziale, kulturelle und sportliche Projekte. Unsere Mission ist es, Bürgerinnen und Bürger, Unternehmen und Kommunen unserer Region mit zuverlässigen Bankdienstleistungen zu...
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Trainee Compliance Specialist
vor 1 Tag
Bad Homburg vor der Höhe, Hessen, Deutschland Taunus Sparkasse VollzeitTrainee 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...
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Trainee Compliance Specialist
vor 1 Tag
Bad Homburg vor der Höhe, Hessen, Deutschland Taunus Sparkasse VollzeitTrainee 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
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 10993-17) • 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 10993-1 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).