Director, Medical Devices EU

Job description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. OBJECTIVES: Acts as the Person Responsible for Regulatory Compliance (PRRC) RA for Takeda’s medical devices with in Takeda´s EU Authorised Representative organization per EU Medical Device Regulation (MDR) 2017/745 . The RA PRRC of the EU Authorised Representative is responsible for ensuring that the tasks of the AR are fulfilled in the context of regulatory requirements Manages the liaisons to key regulatory authorities (e.g. notified bodies, competent authorities and others as required ) in the European Economic Area (EEA) , and others as needed ACCOUNTABILITIES: The PRRC RA role supports the EU Authorised representative duties , such as reviewing and verifying that the technical documentation and Declaration of Conformity are up-to-date and ensures that the documentation is aligned with appropriate regulatory requirements and standards...