University of Galway - UG
University of Galway - UG
Course Code
CERT-MTD
Zone
Attendance
Part time

Course Summary

The Level 8 Certificate 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.

College Link

University of Galway - UG
College Link > CERT-MTD - Medical Technology Regulatory Affairs & Quality

Colleges often have information about the course on their own website, along with other useful information relating to the college. (Note: Not always available)

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

Students with a Level 7 or higher qualification in science or engineering are eligible for this Level 8 programme. Students with a Level 7 or higher qualification in a non-technical subject area but who hold a minimum of two years’ relevant medtech industrial experience in regulatory affairs or quality are also eligible to apply.

Application Details

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).

Next start date September 2025

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

Fees

Fees: EU
€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

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.

Duration

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

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