Closing date for applications: 02/08/2022
Role summary
Responsibilities of the Assessment & Surveillance section in the Medical Devices department include:
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Management of all medical device and in-vitro diagnostic device (IVD) vigilance issues, minimising risk to public health and ensuring compliance to relevant legislation.
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Coordination and implementation of the HPRA’s market surveillance activities for medical device and IVD technologies.
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Designation and ongoing oversight of the performance of notified bodies for medical devices and IVDs .
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Inspection of economic operators
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Assessment of technical and regulatory aspects of medical device and IVD technologies.
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Communication and engagement with stakeholders on medical device and IVD issues.
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Management of Safety/Information notices, competent authority reports/notifications and other case specific communications.
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Development of technical guidance and capabilities at national and EU level.
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Engagement with the European network on medical device and IVD issues, regulatory development and joint working initiatives.
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Contributing to work associated with implementation of relevant legislation, guidance, standards and relevant change and development initiatives.
Key Responsibilities
Strategic Objectives
Operational Objectives
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Assist their Manager, Section Manager and Director for Medical Devices in meeting the objectives, goals and targets of your section and the Medical Devices Department.
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Work with their Manager to plan and organise work tasks and ensure delivery of work.
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Maintain appropriate records of meetings, activities and submit reports as appropriate.
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Assist in the compilation of data for management reports, annual report etc. as required.
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Promote a positive, open, friendly and professional working environment.
For more information please refer to the role profile below. Applications should be submitted via the HPRA Recruitment Portal.
Role Profile Application form