Expert Material Compliance, Biocompatibility

vor 6 Monaten

Frankfurt Am Main, Deutschland Fresenius Medical Care Vollzeit

**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
- Independent working structure, hands on and ‘can do’ mentality
- Attitude to Team Work, ability to work in matrix environment
- Global mindset approach

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