Packaging development expert

vor 3 Wochen

Bad Homburg vor der Höhe, Deutschland Fresenius Medical Care Vollzeit

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. Fresenius Medical Care – Creating a future worth living. More than four decades of experience in dialysis, innovative research, the global leader in dialysis services and products – that is Fresenius Medical Care.

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.)
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. 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
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)
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)
Strong background in chemistry of medical polymers and materials used in contact with blood and the related analytical methods
Good and professional relationship to and communication with international colleagues and superiors
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.)
250, etc.)
Knowledge of internal and external processes and structures and of the (global) corporate Quality Management requirements
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
Fresenius Medical Care Deutschland GmbHReference number R0150814
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.

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