Expert Material Compliance, Biocompatibility
vor 4 Wochen
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/Power Point, 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 Career with a purposeWe offer an opportunity to create and deliver treatments that save and change lives for the better. We’ll support your ongoing development. And you’ll be part of a dedicated team of people who inspire each other to create the best possible healthcare outcomes each and every day. Inclusion and diversityJoining Fresenius Medical Care means becoming part of a team that values diversity. We embrace the wealth of different backgrounds, cultures, experiences and opinions that make up our workforce and strive to create an inclusive atmosphere in which all our employees feel valued. StabilityDeveloping innovative products and continuously improving our renal therapies made us the clear market leader in the production of hemodialysis machines, with sustainable, profitable growth . This position provides our 125000 employees with the stability and security they need to help improve the lives of our patients. Learning and developmentWe offer participation in programs at world-class business schools, leadership development, regular training for our nurses, health care professionals and manufacturing staff and digital access to high-quality educational content for all employees worldwide 24/7. Local benefitsOur employees enjoy both local and global opportunities for growth and personal fulfilment. We offer local benefits designed to suit the requirements of the respective country and place of work to create ideal conditions everywhere. Work-life balanceWe want to empower people to deliver better care. Therefore, we promote a better work-life balance through flexible working hours, part-time models, the possibility to work from home, and more.-
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