Expert Material Compliance, Biocompatibility & Toxicological Evaluation (m/w/d)

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.

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

• 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