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Medical Devices Technology Group Lead

Location: Dublin
Experience:5-7 Years
Job Type:Fixed Term Contract
Salary:Not Disclosed
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May be suitable for: Scientist

Medical Devices Technology Group Lead
Our client, a large regulatory body are currently recruiting for two Technology Group Leaders to join their Assessment and Surveillance Medical Device Group. As Medical Devices Technology Group Lead you will work as part of the Assessment & Surveillance section in the Medical Devices department to assess the technical and regulatory aspects of medical devices. These activities include technical documentation review, vigilance, market surveillance and associated activities, clinical investigation, classification, combination products and registration. As Medical Devices Technology Group Lead you will be reporting to the Assessment & Surveillance Manager.
*A more detailed job specification is available upon request

• Ensure Medical device technologies 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 medical devices 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 assessment of technical data for medical devices is carried out effectively and efficiently e.g. issues arising from market surveillance, vigilance cases or vigilance trends / signals as appropriate
• Ensure that specific projects arising from market surveillance, vigilance cases or vigilance trends / signals are carried out as appropriate
• Work closely with other group and section managers, within the Medical Devices department to achieve objectives relating to medical devices.
• Work with Compliance colleagues who have responsibility for medical device inspections, to ensure that tasks are effectively managed and reviewed as appropriate

• 3rd level degree in a relevant scientific, life-sciences, engineering or related discipline
• A relevant post graduate qualification
• Experience in assessing vigilance issues, reviewing technical aspects of clinical investigations, conducting device classifications, risk analysis and assessing device technical documentation.
• Experience in people management or mentoring staff
• Minimum of three years’ relevant experience in a research, healthcare, industry or regulatory environment (preferably relating to medical devices
• In depth knowledge of medical devices
• Knowledge and understanding of regulatory systems and relevant European and National legislation (current and future) relating to medical devices
• 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
*A more detailed job specification is available upon request

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

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


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