IVDR Project Manager, Assessment & Surveillance - Medical Devices

Closing date for applications: 12/10/2021

 ROLE SUMMARY

Reporting to the Assessment & Surveillance Manager, the IVDR Project Manager will work within the Assessment & Surveillance section in the Medical Devices department to proactively manage the activities associated with the implementation of the in vitro diagnostic medical device Regulation (IVDR) by the Health Products Regulatory Authority (HPRA).

The IVDR Project Manager will be primarily responsible for:

o Coordinating all activities necessary for effective implementation of the IVDR with the Regulatory & Policy Team, the Assessment & Surveillance Manager, the IVD/Medical Device Advisor and the IVD Operations Manager.

o Managing the implementation plan for the IVDR, ensuring it is kept up-to date, actions are agreed and assigned to the relevant internal team and timelines for completion are met.

o Preparing progress reports on IVDR implementation and assisting in the compilation of data and preparation of management reports.

o Providing technical input and expertise to national policy discussions and decisions as part of implementation.

o Contributing to the development of policy documents, position papers, guidance documents, discussion and consultation documents and comments on internal and external draft documents in relation to IVD regulation.

o Participating and engaging in national, European and international meetings relating to IVDR implementation and disseminating information to the relevant internal stakeholders.

 For more information please refer to the role profile below. Applications should be submitted via the HPRA Recruitment Portal


Role Profile              Application Form



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