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.
| Course Category | Medical Technology, Medicine & Healthcare |
| Course Type | Online Learning |
| Course Qualification | Masters Degree |
| Course Start Date | 1st January 1970 |
| Course Duration | 2.5 years |
| Course Time | Part-time |
| Course Fee | 13950 |
| Entry Requirements | Open to students who have obtained a Level 8 primary degree in a science/engineering subject related to the life sciences. Previous or current experience in regulatory affairs (minimum 2 years) may be taken into account in assessing entry qualifications for candidates with relevant Level 7 qualification with appropriate experience. Candidates who have completed modules in cognate programme areas may also enter the programme and gain exemptions as determined by the Programme Committee in accordance with Institutes guidelines. Cases will be assessed on an individual basis by the Programme Committee. Students applying on the basis of formal qualifications and supplementary accredited prior learning (APL) for core pre-requisites will be required to submit full details and references to the Programme Board for consideration of educational equivalencies. Prior experiential learning will be assessed using guidelines recommended by the Academic Council of ATU Sligo and University of Galway. |
This course is free/ funded under the Springboard+ Initiative.
Newly updated 60ECT Programme! The Professional Diploma in Education Home Economics (PDEHE) programme provides an opportunity for registered teachers of other subjects who have an interest in and passion for Home Economics, to acquire the knowledge, attitudes, and practical skills required to teach Home Economics at post primary level.
This programme has been designed to meet the growing requirements of Irish Medical Technology companies in filling regulatory and quality assurance roles.
This programme is run in conjunction with NIBRT (National Institute for Biopharmaceutical Research and Training), with many of the lecturers and guest lecturers from NIBRT.
