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Medical Technology & Regulatory Affairs

Your Course
This programme is being 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 are provided by the Institute of Technology, Sligo, and NUI Galway staff. Additional lecturing, as required, may be provided by outside specialists and practitioners. The programme consists of 12 modules, each of 5 ECTS, delivered over two years (six modules per year), and a research project (30 ECTS), carried out over both years of the programme.

Entry requirements

Minimum Entry Requirements
Candidates must hold at least a Second Class Honours Level 8 primary degree in a related subject area in science or engineering. Prior medical technology industry experience in regulatory affairs will be considered a distinct advantage in assessing applications. Applications from candidates who hold a relevant degree at Level 7, with at least two years' medical technology industry experience in regulatory affairs, will also be considered.


2 years, part-time distance-learning.

Careers or further progression

Career Opportunities
Graduates will be equipped with essential knowledge and skills to work in a Regulatory Affairs environment within the highly successful and growing Irish medical technology industry sector. The Irish Medical Devices Association (IMDA) states that the medical technology sector employs over 25,000 people, with 18 of the world's top 25 medical technology companies maintaining a base in Ireland and a further 50% of the 300 medtech companies being indigenous. The sector is expected to continue to grow, as stated in December 2014 by the Director of the IMDA Sinead Keogh: "IMDA's latest survey shows that confidence within the sector is improving steadily, with nearly half of companies more confident now than they were three months ago and nearly half planning to hire new staff."

Further enquiries

Professor Terry Smith
T: +353 91 492 022


1. This course will equip you with the essential breadth and kind of knowledge, skill 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.

2. Graduates will have the skills and ability to function within, and adapt to, a changing technical work environment and evolving regulatory frameworks.

3. 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.

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