Medical Technologies Regulatory Affairs & Quality

The Level 8 Higher Diploma in Medical Technology Regulatory Affairs and Quality is a two year part-time programme (60 credits). The programme is made available online using a combination of distance-learning / e-learning technologies, with some optional workshops. The educational elements are provided by University of Galway and Institute of Technology Sligo staff. Additional lecturing, as required, may be provided by industry specialists and practitioners.



The programme consists of 12 modules, each worth 5 ECTS. The programme is delivered over four semesters (two academic years). Three modules are delivered per semester.



Assessment of students will be through continuous assessment of each module, which will include written assignments, workshop-based problem solving, and open-book exams using multiple choices, matching questions as well as short and long answer questions.

Graduates who have a level 7 qualification in a relevant area of Science, Engineering or Technology are eligible to apply for this programme. Applications from candidates who hold a Level 7 primary degree in a non-technical subject, and who have at least five years medical technology industry experience in quality and /or regulatory affairs will be considered. Candidate interviews may be used to assess candidates’ suitability for the programme.



International students, whose first language is not English, will be required to prove their English competency through their school leaving examination or matriculation examination or by achieving the minimum standard in a recognised English language test, i.e., IELTS English language proficiency of 6.5 (with no band less than 6.0 in each element of the test) or equivalent.



International students, whose first language is not English, will also need to provide evidence of their oral communication skills at interview. In addition to demonstrating their English language competency, they will need to provide evidence of having relevant experience in research (laboratory and/or computational desk based research) at undergraduate level or post-graduation.

Applications must be completed online at: https://nuigalway.elluciancrmrecruit.com/Apply/Account/Login.



An application requires a registration fee of €35. You will be asked to upload proof of identification, academic transcripts, a personal statement, an academic reference and documentation to fulfil the English requirement (where English is not your first language).

1 year (2 semesters), part-time distance learning (100% online).

Next start date September 2025



Closing Date

No set closing date. Offers made on a continuous basis.

Career Opportunities

This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs environment within the global Medical Technology industry sector. It has been specifically designed to meet the growing requirements of 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 in conjunction with a taskforce comprised of regulatory experts from industry and industry practitioners.



Regulatory Affairs within the medical technology products sector is a relatively young, multidimensional profession that is international in scope. Operationally, a Regulatory Affairs professional is responsible for ensuring that pertinent government obligations, market-driven demands, and evolving scientific conventions are understood and addressed by various stakeholders of the medical and health care system. Given the evolving nature of international regulations, a regulatory affairs professional must continually grow their knowledge and skills to be effective and to advance in their careers.



Regulatory professionals at all career and experience levels are involved in activities throughout the product lifecycle, and are involved to some degree in bridging the gap between regulatory-related functions and organisation and business activities.



The Irish MedTech Association (IMA) asked senior MedTech industry executives to identify the current number of employees required to meet current skills demand, as well as forecasted number of employees required in MedTech organisations up to 2020. The IMA report (2017) has estimated that 4,000 additional Medical Technologies jobs will be added by 2020, with a 43% increase in staff numbers in the regulatory affairs functions and 17% in Quality roles. Over 30,000 people are employed in the highly successful and growing Irish Medical Technology industry sector, representing one of the leading global hubs of MedTech industries.