Course Summary
The Level 8 Higher Diploma in Medical Technologies Regulatory Affairs and Quality provides students with an introduction to the core elements of the product development lifecycle and the associated role of a Medical Technology Regulatory Affairs and/or Quality professional. The programme ensures that students acquire a good, fundamental understanding of all applicable regulations and skills to address the ever-changing environment of Medical Technologies Regulatory Affairs and Quality.
College Link
Career Sectors
This course prepares you for working in the Career Sectors below. Follow the links to get a fuller understanding of the sectors you are preparing for.
Entry Requirements
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.
Application Details
How to apply
We encourage all applicants to apply as early as possible.
Review/Closing Dates (for Taught Programmes)
For most programmes, University of Galway does not set specific closing dates for receipt of applications. Applications will be accepted on a rolling basis and course quotas will be reviewed continuously throughout the application cycle with the exception of applications for some programmes which are reviewed after the specified closing date. Candidates who do not have their final degree marks available may be made a conditional (provisional) offer.
Online Application
Applications to most postgraduate programmes at University of Galway are made online via www.universityofgalway.ie/apply (see "Application Weblink").
Next start date: September 2024.
Review/Closing Dates (for Taught Programmes)
For most programmes, University of Galway does not set specific closing dates for receipt of applications. Applications will be accepted on a rolling basis and course quotas will be reviewed continuously throughout the application cycle with the exception of applications for some programmes which are reviewed after the specifed closing date*. Candidates who do not have their final degree marks available may be made a conditional (provisional) offer.
Fees
€4,500 p.a. 2024/25
Fees: Tuition
€4,444 p.a. 2024/25
Fees: Student levy
€56 p.a. 2024/25
Fees: Non EU
€8,000 p.a. 2024/25
For information on possible fee support available through Next Level Skillnet to eligible applicants, please contact [email protected] or [email protected].
Note: To be eligible for EU (as opposed to the higher Non-EU) fee rates, applicants must qualify through Nationality or Residency. For further information visit https://www.universityofgalway.ie/student-fees/international/
The Student
Career Interests
This course is typically suited for people with the following Career Interests. If these interests do not describe you, this course may prepare you for work you may not find satisfying.
Administrative
Administrative people are interested in work that offers security and a sense of being part of a larger process. They may be at their most productive under supervisors who give clear guidelines and while performing routine tasks in a methodical and reliable way.
They tend to enjoy clerical and most forms of office work, where they perform essential administrative duties. They often form the backbone of large and small organisations alike. They may enjoy being in charge of office filing systems, and using computers and other office equipment to keep things running smoothly. They usually like routine work hours and prefer comfortable indoor workplaces.
Career Progression
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.
Further Education
Following completion of the Higher Diploma (60 credits) students are eligible to apply to undertake the MSc in Medical Technologies Regulatory Affairs, a part-time distance learning Level 9 programme jointly delivered by University of Galway and IT Sligo.