- IVDs are safe and perform as intended without posing undue risk to patients or public health.
- Responses to all issues that arise in relation to IVDs are managed effectively and efficiently and to ensure that appropriate action is taken to minimise the risk to public health and ensure compliance to relevant legislation.
- The assessment of technical data for IVDs is carried out effectively and efficiently e.g.
- issues arising from market surveillance, vigilance cases or vigilance trends / signals as appropriate.
- Specific projects arising from market surveillance, vigilance cases or vigilance trends / signals are carried out as appropriate.
- The HPRA communicates effectively, both internally and externally on IVD issues and provides relevant information on IVDs and on our activities.
- 3rd level degree in a relevant scientific, life-sciences, engineering or related discipline. o Minimum of three years' relevant experience in a research, healthcare, industry or regulatory environment (preferably relating to IVDs).
- In depth knowledge of IVDs.
- Knowledge and understanding of regulatory systems and relevant European and National legislation (current and future) relating to IVDs.
- Be a self-starter, capable of excellent communication, negotiation and decision making.
- A strong personal work ethos and a proven ability to manage high work throughputs and manage deadlines.
- An ability to adapt to changing conditions and display ability to generate effective and pragmatic solutions to new situations and problems. oHave excellent organisational skills and can demonstrate initiative and team working capabilities.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales