Flexible Working
Learning & Development
Wellbeing

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

Salary €44,831-€74,404 per annum
Location Hybrid
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This is a Temporary, Full Time vacancy that will close in {x} days at {xx:xx} BST.

The Vacancy

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.

It is envisaged that the successful candidate in this role will undertake a broad range of regulatory activities in device assessment throughout the product lifecycle including implementation of the new medical device regulation and new 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

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Published

Not Published

Closing

in X days

{Expiry}