Medical Technologies Regulatory Affairs & Quality

The Higher Diploma in Medical Technology Regulatory Affairs and Quality programme 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 jointly by University of Galway and ATU Sligo, in conjunction with external professionals and industry practitioners who have all the required expertise, knowledge, skills and experience to deliver the education and training required to the highest international standards.



The course will link the existing regulations to regulatory requirements and how those requirements are executed across the medical device lifecycle, for example; how to develop technical documentation for regulatory submissions (regulatory affairs professionals), how to perform vigilance post market surveillance requirements (Vigilance specialist), core quality management standards and requirements (QA or Compliance Specialist) and testing requirements to demonstrate safety and efficacy of a medical device (R&D Engineer).



Regulatory Affairs and Quality personnel within the medical technology products sector are responsible for assuring that pertinent government obligations, market-driven demands, and evolving scientific conventions are understood and addressed by various stakeholders of the medical and healthcare system. Given the evolving nature of international regulations regulatory affairs and quality assurance professionals must continually grow their knowledge and skills to be effective and to advance in their careers. This course will ensure the development and enhancement of those skills.

Year 1



Semester 1 Modules (each module is 5 ECTS)



Introduction to Quality Management Systems

Fundamentals of EU Medical Device Regulations

Auditing and Compliance

Semester 2 Modules (each module is 5 ECTS)



Fundamentals of US Medical Device Regulations

Risk Assessment

Validation and Calibration



Year 2



Semester 3 Modules (each module is 5 ECTS)



Fundamentals of Global Medical Device Regulations

Sterilisation & Biocompatability

Operations Management. and GMP

Semester 4 Modules (each module is 5 ECTS)



Fundamentals of Medical Device Clinical Trials

Introduction to Market Vigilance & Labelling

Technical Report Writing

Curriculum Information

Curriculum information relates to the current academic year (in most cases).

Course and module offerings and details may be subject to change.

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.

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

Next start date September 2026



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.