Course Summary
The Level 8 Certificate in Medical Technologies Regulatory Affairs and Operations has been specifically designed to meet the growing requirements of medical technology companies in filling regulatory and quality assurance roles, introducing a focus on operations.
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
- 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.
- 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 IT Sligo and University of Galway.
- All applicants, whose first language is not English must present a qualification in the English language e.g. IELTS (no less than 6.5 in ANY component); TOEFL ((no less than 88 in ANY component); and Pearson (no less than 61 in ANY component). NOTE: Language tests must be undertaken no more than two years prior to commencement of your programme at the University.
Application Details
IMPORTANT: To find out how to apply for the course please contact [email protected] or [email protected].
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
The Level 8 Certificate was previously approved as a HEASpringboard course.
Springboard Fees 2023/24: €3,500; government-funded for those classified as unemployed. €350 (10%) Fee for employed participants.
To apply for the Certificate through Springboard please go to https://springboardcourses.ie/details/8169
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 or Quality environment within the highly successful and growing Irish Medical Technology industry sector, with over 30,000 people currently employed.
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, industry practitioners and representatives from the regional skills for a west and north west.
The Irish Medtech Association (IMA) Skillnet invited 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 further opportunities in Quality and Operations roles.
Further Education
Following completion of the one year Level 8 Certificate in Medical Technology Regulatory Affairs and Quality (30 credits) students are eligible to continue for a second Year to complete a Level 8 Higher Diploma in Medical Technology Regulatory Affairs and Quality (60 credits).
Graduates with the Higher Diploma award will be 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.