Medical Devices Regulatory and Policy Assessor, Regulatory & Policy – Medical Devices

Closing date for applications: 31/08/2019

The Medical Devices Regulatory and Policy Assessor will work as part of the Communication & Policy Team within the Regulatory and Policy section of the Medical Devices department.  The Regulatory and Policy Assessor will contribute to the planning, coordination, development and implementation of the legislative requirements for medical devices and in vitro diagnostic medical devices at national and European levels. The Regulatory and Policy Assessor will help inform policy and development decisions and, if required support the planning and development of medical device activities within the Health Products Regulatory Authority (HPRA).

 

These activities are undertaken with the aim of ensuring that medical device and in-vitro diagnostic technologies in Ireland and Europe are in compliance with national and European requirements and relevant standards. The section’s overall objective is to help ensure:

  • The HPRA’s medical device activities are appropriate, prioritised and relevant to the stakeholders that we serve;
  • The HPRA is consistent and clear in its policy and regulatory approach to medical devices and in-vitro diagnostics;
  • The HPRA communicates effectively, both internally and externally on medical devices and in-vitro diagnostic issues and provides relevant information on devices and on our activities;
  • Departmental activities are completed with administrative, clinical, legal, regulatory, technical and scientific excellence.

     

    The Communication & Policy Team’s overall objective is to:

  • Ensure the HPRA is consistent and clear in its policy and regulatory approach to medical devices and in-vitro diagnostics;
  • Implement and maintain the EU Regulations on medical devices and in-vitro diagnostic devices and the related EU and national legislation in an effective and timely manner;
  • Develop and deliver effective communication, reporting and training initiatives, both internally and externally on medical devices and in-vitro diagnostic issues and on our activities and contribute to the development of communication material;
  • Ensure that the assessment of regulatory compliance and application of the medical device legislation is carried out effectively and efficiently across the HPRA’s medical device regulatory activities (e.g. process development, device classification, input into market surveillance cases);
  • Ensure effective and efficient responses to all medical device queries on regulatory and policy issues.
  • Input into the coordination of the HPRA’s medical device activities ensuring they are appropriate, and relevant to the stakeholders that we serve;

 

The Regulatory & Policy Assessor will report to the Communication & Policy Lead and will contribute to the planning co-ordination and implementation of the communication and policy activities for medical devices both within the organisation and at a national/international level. 


Role Profile   Application form



« Back