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

In your role asMaterial Compliance, Biocompatibility & Toxicological Expert (m/f/d) you will beresponsible for biocompatibility evaluation of medical devices according to the Regulation (EU) 2017/745 on medical devices (MDR), ISO 10993-series and other regulatory guidelines/requirements and to ensure documentation of EHS compliance of FME’s product portfolio.

Your tasks

• 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)
• Providing expert advice (e.g. author of expert statements)
• Acting as sponsor, study monitor and contact for chemical/biocompatibility studies in internal and external laboratories (creation of test plans, test protocols, review, and approval of test reports)
• Compilation of overall biological safety assessment according to ISO 10993-1
• Evaluation of raw materials as well as finished products concerning regulatory EHS-requirements on substances and materials (REACH, POP, MDR, CLP, Packaging etc.) 
• Contact person to external suppliers concerning the before mentioned requirements
• Support regulatory affairs and value stream interfaces with required information regarding material compliance, e.g. tender requests
• Support development of biocompatibility evaluation strategies
• Support regulatory compliance, speed up time 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)
• Collaborate with engineering teams from the early stages of development to provide quality assurance input and support
• Expert within cross functional teams concerning EHS material compliance and biocompatibility questions
• Support in second source and material change projects

Your profile

• Successfully completed scientific background (master’s degree) in toxicology, chemistry, biology, or related fields
• First years of experience in regulatory affairs or quality environment in pharmaceutical/medical device field
• Biocompatibility evaluations and toxicological expert statement (related to the ISO10993 series)
• Strong background in chemistry of medical polymers and materials used in contact with blood and the related analytical methods
• 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. ISO 13485, ISO 14971, ICH Q10, EU GMP, FDA 21 CFR §820.1, etc.)
• Knowledge of internal and external processes and structures and of the (global) corporate quality management requirements
• 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 independently as well as within the cross-functional team
• Fluent in English, in written and spoken, and a good knowledge of German