Closing date for applications: 23/10/2019
ROLE SUMMARY
Responsibilities of the Assessment & Surveillance section in the Medical Devices department include:
o Management of all medical device and in-vitro diagnostic medical device (IVD) vigilance
issues, minimising risk to public health and ensuring compliance to relevant legislation.
o Coordination and implementation of the HPRA’s market surveillance activities for medical devices and IVDs.
o Designation and ongoing oversight of the performance of notified bodies for medical devices and IVDs.
o Assessment of technical and regulatory aspects of medical devices and IVDs.
o Communication and engagement with stakeholders on medical device and IVD issues.
o Management of Safety/Information notices, Competent Authority reports/notifications
and other case specific communications.
o Development of technical guidance and capabilities at national and EU level.
o Engagement with the European network on medical device and IVD issues, regulatory
development and joint working initiatives.
o Contributing to work associated with implementation of relevant legislation, guidance, standards and relevant change and development initiatives.
Working within the Medical Devices department, the Scientific Officer will contribute to all activities relating to IVDs in the Medical Devices Assessment & Surveillance section of the Medical Devices department.
The Scientific Officer will work closely with their Manager and will maintain effective working relationships in particular with other members of the Medical Devices Assessment & Surveillance section, the Regulatory and Policy section and the Clinical section, along with the Compliance department and other departments as required.
Applications should be submitted via the HPRA Recruitment Portal.
Role Profile Recruitment portal application form