Scientific Officer, Assessment & Surveillance (Medical Devices)

Closing date for applications: 02/08/2022

Role summary

Responsibilities of the Assessment & Surveillance section in the Medical Devices department include:

  • Management of all medical device and in-vitro diagnostic device (IVD) vigilance issues, minimising risk to public health and ensuring compliance to relevant legislation.

  • Coordination and implementation of the HPRA’s market surveillance activities for medical device and IVD technologies.

  • Designation and ongoing oversight of the performance of notified bodies for medical devices and IVDs .

  • Inspection of economic operators

  • Assessment of technical and regulatory aspects of medical device and IVD technologies.

  • Communication and engagement with stakeholders on medical device and IVD issues.

  • Management of Safety/Information notices, competent authority reports/notifications and other case specific communications.

  • Development of technical guidance and capabilities at national and EU level.

  • Engagement with the European network on medical device and IVD issues, regulatory development and joint working initiatives.

  • Contributing to work associated with implementation of relevant legislation, guidance, standards and relevant change and development initiatives.

 

Key Responsibilities

Strategic Objectives

  • Support evolving business needs and strategic requirements of the department in undertaking new areas of technical responsibilities in line with these developments.

Operational Objectives 

  • 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.

  • Work with their Manager to plan and organise work tasks and ensure delivery of work.

  • Maintain appropriate records of meetings, activities and submit reports as appropriate.

  • Assist in the compilation of data for management reports, annual report etc. as required.

  • 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



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