Flexible Working
Learning & Development
Wellbeing

Scientific Officer, Assessment & Surveillance, Inspections - Medical Devices / Oifigeach Eolaíochta, Measúnú & Faireachas, Cigireachtaí - Feistí Leighis

Salary €44,331-€73,668 per annum (incremental scale)
Location Hybrid
{Mergefield Value}
{Mergefield Value}

This is a Temporary, Full Time vacancy that will close in {x} days at {xx:xx} BST.

The Vacancy

Reporting to the Medical Device Inspection Operations Manager, the Medical Devices Inspections Scientific Officer will work to: 

  • Support the planning and execution of proactive and reactive inspections of manufacturers and other economic operators as part of the HPRA market surveillance activities for medical devices.
  • Support the planning and execution of inspections relating to designation of notified bodies for medical devices in Ireland and as part of European joint assessment activities.
  • Support the planning and execution of inspections arising from the HPRA ongoing surveillance and monitoring programme for Notified Bodies, including observation of audits conducted by the Notified Bodies.
  • Assist in coordinating actions in relation to cases.
  • Assist in managing queries and will respond when it is appropriate to do so.
  • Assist in the development and maintenance of the quality management system for inspection activities.
  • Ensure that accurate regulatory information is provided to and understood by economic operators and that medical devices and IVDs assessed/inspected, comply with relevant regulatory requirements
  • Provide support on inspections as required.
  • Ensure that specific projects are carried out as required.
  • Provide support and technical advice within the Medical Devices Department as required.

The Scientific Officer will work closely with their Manager and will maintain effective working relationships with colleagues within the Inspection Team and in other sections and departments of the HPRA, and with stakeholder sections, to ensure that inspection issues requiring cross-functional input are effectively investigated and followed up on. 

It is envisaged that the successful candidate in this role will undertake a broad range of regulatory activities in the inspection team throughout the inspection lifecycle including implementation of the medical device regulation and IVD regulation at both a European and national level. 

The Company

We are the Health Products Regulatory Authority (HPRA) and we regulate medicines and devices for the benefit of people and animals. We are committed to excellence in health product regulation through science, collaboration and innovation.

Our remit and regulatory functions include human and veterinary medicines, clinical trials, medical devices, controlled drugs, blood and blood components, tissues and cells, and cosmetic products.

The Benefits

Flexible
working

Learning & Development

Wellbeing

Employee Assistance Programme

Beneficial Leave Policies

Pension Scheme

Alternatively, please sign in with...

Published

Not Published

Closing

in X days

{Expiry}