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In Vitro Diagnostics Operations Manager

Location: Dublin
Experience:3-4 Years
Job Type:Fixed Term Contract
Salary:Not Disclosed
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In Vitro Diagnostics Operations Manager
Our client, a national regulator, are currently recruiting for an In Vitro Diagnostics (IVD) Operations Manager. As IVD Operations Manager you will work as part of the Assessment & Surveillance section in the Medical Devices department to assess the technical and regulatory aspects of IVDs. These assessment activities include technical documentation review, vigilance, market surveillance and associated activities, performance evaluations, classification and registration.

• Ensure IVDs are safe and perform as intended without posing undue risk to patients or public health
• Ensure 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
• Ensure 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
• Communicate effectively, both internally and externally on IVD issues and provide relevant information on IVDs

• 3rd level degree in a relevant scientific, life-sciences, engineering or related discipline
• Minimum of three years’ relevant experience in a research, healthcare, industry or regulatory environment (preferably relating to IVDs)
• In depth knowledge of IVDs
• Experience in assessing vigilance issues, reviewing technical aspects of performance evaluations, conducting IVD classifications, risk analysis and assessing IVD technical documentation
• 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
• Have excellent organisational skills and can demonstrate initiative and team working capabilities
• Experience in people management or mentoring staff
• Availability to travel for European and international meetings will be a requirement in this role

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252


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