(Senior) Expert Material Compliance, Biocompatibility and Toxicology Evaluations (m/w/d)

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
• Experience of 2-3 years in Regulatory Affairs or Quality environment in pharmaceutical/medical field
• 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
• Advanced knowledge of medical device risk management and related regulations
• Advanced knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 2017/745, MDSAP etc.)
• Advanced knowledge of applicable standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CFR §820.250, etc.)
• General knowledge of FDA 510(K) requirements
• 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