Scientific Officer, Regulatory & Policy - Medical Devices

Closing date for applications: 24/02/2019

ROLE SUMMARY

Working with the Medical Devices Regulatory and Policy section, the Scientific Officer will contribute to the planning, coordination and implementation of the communications and policy activities in the Regulatory and Policy section of the Medical Devices Department. The Scientific Officer will help support the planning and development of medical device activities within the Health Products Regulatory Authority (HPRA).

The Scientific Officer will work closely and maintain effective working relationships in particular with the other members of the section, the Devices Assessment & Surveillance section, the Clinical section, the Compliance department and with the Legal and Communications sections. The Scientific Officer will help to ensure effective co-ordination and co-operation across all areas of our medical device activities and to ensure that the objectives of the Medical Devices department are met.

Working within the medical devices Regulatory and Policy team, the Scientific Officer will work to:
o Ensure effective and efficient responses to all medical device queries on regulatory and policy issues.
o Contribute to the implementation of the communications strategy and the development of communication material.
o Ensure that accurate regulatory information is provided to and understood by economic operators and that medical devices assessed comply with relevant regulatory requirements.
o Contribute to the implementation of the training strategy and development of material as required.
o 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, input into market surveillance cases).
o Ensure that specific projects are carried out as required (e.g. implementation of the EU medical device regulations, development of new regulatory processes as a result of Brexit, input into European Joint Actions where relevant).
o Provide support and technical advice within the Medical Devices Department as required.


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