Master of Science in Medical Technology Regulatory Affairs

This programme has been designed to meet the growing requirements of Irish Medical Technology companies in filling regulatory and quality assurance roles. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed jointly by University of Galway and ATU Sligo in conjunction with an industry taskforce comprised of regulatory experts from Irish Medtechs Regulatory and Quality Working Group. The development of the programme is supported by the Irish Medtech Skillnet and contracting organisation, the Irish Medtech, the Ibec group that represents the Medical Technology sector.The course will enable Regulatory Affairs personnel in the Medical Technology industry to understand all current device and diagnostic regulations and to develop the skills necessary to address and prepare for the ever-changing global environment of regulatory affairs. Upon successful completion of the programme, participants receive an MSc award at NFQ Level 9.Programme objectives:To produce graduates with the essential breadth and kind of knowledge, skills set and competencies required to function as a regulatory affairs professional in the medical device industry and to be capable of an immediate contribution to regulatory projects and projects with a regulatory element in a medical device company environment.To ensure that participants have sufficient skills and knowledge to employ appropriate advanced data analysing, synthesising, summarising and research skills in a regulatory environment.To ensure that participants can effectively communicate and defend scientific data and findings in a variety of forms to regulatory agencies, medical care systems, internal personnel and the public.To ensure participants have the skills and ability to function within, and adapt to, a changing technical work environment and evolving regulatory frameworks.To ensure the participants can provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to people around the world.Course outlineThe programme consists of a two year part-time Level 9 MSc in Medical Technology Regulatory Affairs (90 credits). The programme shall be made available online using a combination of distance-learning / e-learning technologies and some face to face workshops for an overall blended learning approach. The educational elements will be provided by the ATU Sligo, and University of Galway staff. Additional lecturing, as required, may be provided by outside specialists and practitioners.The programme consists of 12 modules, each worth 5 ECTS. The programme is delivered over 2-2.5 years. Three modules are delivered per semester. A dissertation (30ECTS) is also carried out over year 1 and year 2.Please watch our course video to find out more about the course with testimonials from graduate Ida Foley of Teleflex, industry Regulatory experts Robbie Walsh formerly of Boston Scientific and John Kilmartin formerly of Medtronic, Emer Sherry of the Irish Medtech Association and the Atlantic Technological University Sligo and University of Galway course directors.Who teaches this course?The programme will be delivered by academic staff from University of Galway and ATU Sligo, with expertise in Regulatory Affairs, with guest lectures and workshops involving Regulatory Affairs experts from the Medical technology industry sector.Funding OpportunityThe Irish Medtech Skillnet will also support the participation of 15 students undertaking the MSc. degree programme. You can read more about this funding here.