Assessment & Surveillance Lead, Medical

CPL

Dublin, Dublin City Centre

We currently have an exciting new opportunity for a Technology Group Lead, Assessment & Surveillance - Medical Device. This is a 3 year contract role. ROLE SUMMARY. The medical devices technology group lead 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 assessment activities include technical documentation review, vigilance, market surveillance and associated activities, clinical investigation, classification, combination products and registration. KEY RESPONSIBILITIES. Strategic objectives. Operational Objectives. Technical Management. Market Surveillance & vigilance. Classification and qualification of medical devices. Clinical investigation & compassionate use applications. Quality and Knowledge Management. Performance Management. Team Development/People Management. Communications/Customer Service. QUALIFICATIONS AND EXPERIENCE. To be considered for this post, candidates must have: 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 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. In addition to this the ideal candidate will have; 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. If you are interested in applying for this role please call Linda on +353 1 2784671 or email Ldunne@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com. m. This job originally appeared on RecruitIreland.com.

1830 days ago