In your role as Biocompatibility & Toxicological Expert (m/f/d) you will be partner to product development teams to ensure compliant and safe products regarding biocompatibility & toxicological, engineering teams are supported with a value-added mindset.

Your tasks

Biocompatibility evaluation of medical devices in the framework of Regulation (EU) 2017/745 on medical devices (MDR), ISO 10993-series and other regulatory guidelines/requirementsDefine  biocompatibility evaluation strategies for design & development projectsExpert within cross functional teams concerning material compliance and biocompatibility questionsPerformance 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 adviceActing as sponsor, study monitor, and contact for chemical/biocompatibility studies in internal and external laboratoriesCompilation of overall biological safety assessment according to ISO 10993-1

Your profile

Successfully completed bachelor’s or master’s degree in scientific or engineering or a similar technical field required, such as medical technologySeveral years related experience or an advanced degree without experience or equivalent directly related work experienceExperience in writing biocompatibility evaluations and toxicological expert statementsApplication of Design Control and Risk Management and knowledge and familiarity with the concepts of FDA CFR 820, ISO13485, IEC 60601 and ISO 14971Knowledge with medical device risk management and related regulationsKnowledge with biocompatibility-testing of Medical Devices according to ISO 10993Ability to communicate technical information to non-technical audienceVery good presentation and communication skillsFluent in German and English, in written and spoken