Biocompatibility & Toxicological Expert (m/f/d)

In your role as Biocompatibility & Toxicological Expert (m/f/d)you will bepartner 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/requirements
• Define  biocompatibility evaluation strategies for design & development projects
• Expert within cross functional teams concerning material compliance and biocompatibility questions
• 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
• Acting as sponsor, study monitor, and contact for chemical/biocompatibility studies in internal and external laboratories
• Compilation 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 technology
• Several years related experience or an advanced degree without experience or equivalent directly related work experience
• Experience in writing biocompatibility evaluations and toxicological expert statements
• Application of Design Control and Risk Management and knowledge and familiarity with the concepts of FDA CFR 820, ISO13485, IEC 60601 and ISO 14971
• Knowledge with medical device risk management and related regulations
• Knowledge with biocompatibility-testing of Medical Devices according to ISO 10993
• Ability to communicate technical information to non-technical audience
• Very good presentation and communication skills
• Fluent in German and English, in written and spoken