Assessment & Surveillance Manger, Assessment & Surveillance - Medical Devices

Closing date for applications: 05/05/2021

ROLE SUMMARY

 

The Assessment & Surveillance section in the Medical Devices department is responsible for:

  • Coordination and management of all reactive and proactive activities relating to all medical device and in-vitro diagnostic device vigilance and market surveillance issues, minimising risk to public health and ensuring compliance to relevant legislation.
  • 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.
  • Development of assessment team capabilities and expertise in line with departmental needs and regulatory/technological change.
  • Development of assessment activities relating to growing and newly emerging technology areas, such as in-vitro diagnostics, device-drug combination products and digital technologies.
  • Ensure compliance of medical device economic operators relevant to Ireland, including manufacturers, authorised representatives, distributors and importers, and that they fulfil their responsibilities under the Regulations.

 

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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