Scientific Officer, Assessment & Surveilance - Medical Devices

Closing date for applications: 08/11/2020

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

• Management of all medical device 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 in-vitro diagnostic device technologies.
• Designation and ongoing oversight of the performance of notified bodies for medical devices and in-vitro diagnostic devices.
• Assessment of technical and regulatory aspects of medical device and in-vitro diagnostic device technologies.
• Communication and engagement with stakeholders on medical device and in-vitro diagnostic device 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 in-vitro diagnostic device issues, regulatory development and joint working initiatives.
• Contributing to work associated with implementation of relevant legislation, guidance, standards and relevant change and development initiatives.