Director, Regulatory Affairs Medical Devices & Combination Product

Acts as thePerson Responsible for Regulatory Compliance (PRRC) RA forTakeda’s medical deviceswithinTakeda´sEUAuthorised Representative organization perEU Medical Device Regulation (MDR)2017/745.

The RA PRRC of the EU Authorised Representativeis responsible forensuring 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 asrequired)in the European Economic Area (EEA), and others as needed

The PRRC RA role supports theEU Authorised representative duties, such asreviewing andverifyingthat the technical documentation and Declaration of Conformity are up-to-dateand ensures that the documentation is aligned withappropriateregulatoryrequirements and standards

Verifies that device registration has been appr...