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

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