The Level 8 Certificate in Medical Technologies Regulatory Affairs and Quality is designed to meet the growing demand within medical technology companies for skilled professionals in regulatory, quality assurance and operations roles. Developed in response to industry needs, the programme was created jointly by the University of Galway and ATU Sligo, in collaboration with regulatory experts and industry practitioners, ensuring delivery to the highest international standards.

The course links regulatory requirements to their practical application across the medical device lifecycle, including technical documentation for submissions, post-market vigilance and surveillance, quality management systems, compliance standards, and testing requirements to demonstrate safety and efficacy. Students gain a strong foundational understanding of current device and diagnostic regulations and develop the skills needed to navigate the evolving global regulatory environment.

The programme introduces the core elements of the product development lifecycle and the role of Regulatory Affairs and Quality professionals, with a focus on operational implementation. Upon successful completion, participants are awarded an NFQ Level 8 Certificate worth 30 credits.

Who is this course for?

This course is designed for professionals working in, or aspiring to enter, the Medical Technology, pharmaceutical, or related life-science sectors who wish to develop specialist expertise in Regulatory Affairs. It is ideal for those seeking career progression into regulatory, operations or quality roles, graduates aiming to build industry-relevant skills, and employees who need a recognised qualification to support their development in compliance, product approval, and regulatory compliance functions. It also suits individuals looking to transition into MedTech from scientific, engineering, or healthcare backgrounds and those seeking flexible, part-time study while working.

What will I study?

The Level 8 Certificate in Medical Technology Regulatory Affairs and Quality is a one-year, part-time programme worth 30 ECTS, delivered over two semesters (September–May). It is offered online via distance-learning technologies, with one optional workshop. Teaching is provided by staff from the University of Galway and Atlantic Technological University Sligo, with additional input from industry specialists where required.

The programme consists of six modules, with three delivered per semester. Students must successfully complete all six modules to obtain the Level 8 Certificate award. Assessment is based on continuous assessment and includes written assignments, e-tivities, problem-solving activities, and online open-book exams incorporating multiple-choice, matching, and short and long answer questions.

 Semester 1 modules (each module is 5 ECTS)

1. Introduction to Quality Management Systems
2. Fundamentals of EU Medical Device Regulations
3. Auditing and Compliance

 Semester 2 modules (each module is 5 ECTS)

1. Fundamentals of US Medical Device Regulations
2. Risk Assessment
3. Validation and Calibration

• Industry-designed curriculum developed in collaboration with a taskforce of regulatory experts and MedTech practitioners to directly address real-world skills needs.
• Specialist focus on Regulatory Affairs and Quality within the global medical technology sector, preparing graduates for high-demand professional roles.
• Lifecycle-integrated approach highlighting the role of regulatory professionals across the full medical device product lifecycle and organisational operations.
• Global and future-focused perspective reflecting the evolving, international nature of regulatory frameworks and compliance requirements.
• Career progression and upskilling pathway supporting both new entrants and existing professionals to advance within regulatory and quality functions.
• Strong employability relevance aligned with sector growth, including significant projected increases in regulatory and quality roles within Ireland’s MedTech industry.

The Level 8 Higher Diploma and Certificate in Medical Technology Regulatory Affairs and Quality has been specifically designed to meet the growing requirements of medical technology companies in filling regulatory and quality assurance roles. The development of this specialist programme was driven by industry demand, with content informed by a taskforce comprising regulatory experts, industry practitioners and representatives from the Regional Skills Forum for the West and North West.

The Irish Medical Devices Association (IMDA) highlights the scale and importance of the sector, stating:

“The medical technology sector in Ireland is recognised as one of the five global emerging hubs. The sector employs over 29,000 people and is the second largest employer of medtech professionals in Europe. Ireland is one of the largest exporters of medical products in Europe, with annual exports of €12.6 billion, and companies here directly export to over 100 countries worldwide. As many as 18 of the world’s top 25 medical technology companies have a base in Ireland and 50% of the 450 medtech companies based here are indigenous.”

Senior business leaders were consulted to identify both current and projected skills requirements across the sector. Their responses estimated that approximately 4,000 additional jobs would be created by 2020, particularly within regulatory and quality functions. Key areas highlighted included:

• Regulatory Affairs: 54 additional roles (43% increase from 2016)
• Quality Assurance: 287 additional roles (17% increase from 2016)

As a highly regulated industry, all disciplines involved in the design, manufacture and distribution of medical devices are governed by stringent regulatory frameworks. Given the critical role of regulatory expertise throughout the entire medical device product lifecycle, there is a clear and sustained need for specialised education and training in this field. This requirement is further supported by the Forfás National Skills Bulletin (2016), which identified skills shortages in regulatory professionals and quality control engineers.

Source: Irish Medtech Association Skills Needs Assessment Stakeholder Survey – “Future Skills Needs Analysis for the Medical Technology Sector in Ireland to 2020”

Dr Olivia McDermott (University of Galway) — Associate Professor/Course Co-Director (University of Galway)

• Ms Mary Butler (ATU Sligo) — Co-Director
• Dr Olivia McDermott (University of Galway) —  Lecturer
• Ms Deidre Barrow (Med Tech Regulatory Affairs Consultant) — Lecturer
• Dr Sandra Ganly (University of Galway )— Lecturer
• Dr Stephen Daly (ATU Sligo) — Lecturer
• Dr Ailish Breen (ATU Sligo) — Lecturer
• Dr Mary Garvey (ATU Sligo) — Lecturer
• Dr Yvonne Lang  (ATU Sligo) — Lecturer
• Mr Brian Coll (ATU Sligo) – Lecturer

How will I learn?   

The cert in Medical Technology Regulatory Affairs and Quality combines innovative teaching methods with practical, hands-on learning to ensure a comprehensive educational experience. The programme is delivered online through a combination of distance-learning and e-learning technologies. The educational content will be delivered by staff from Atlantic Technological University, Sligo and the University of Galway.

How Will I Be Assessed?

Assessment is carried out through continuous evaluation across each module and includes a combination of written assignments, quiz-based assessments, problem-solving activities, and open-book examinations. These exams incorporate multiple-choice and matching questions.

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 ATU Sligo.

The University of Galway Course Director Dr Olivia McDermott is on the Elsevier/Stanford University  “Top 2%” Top Scientists list for her research.  

Course Director (Galway): 
Dr Olivia McDermott
E: olivia.mcdermott@universityofgalway.ie

Course Director (Sligo): 
Ms Mary Butler 
Atlantic Technological University, Sligo
E: mary.butler@atu.ie

Lecturer and Medical Technology Regulatory Affairs consultant:
Deirdre Barrow
E: deirdre.barrow@atu.ie   

Administrator (Galway): 
medtech@universityofgalway.ie

The University of Galway recognises that knowledge and skills can be acquired through a wide range of learning experiences. This aligns with the goals of the National Framework of Qualifications (NFQ), which seek to recognise all learning achievements by supporting the development of alternative pathways to qualifications and facilitating the Recognition of Prior Learning (RPL).

Prior experience within the medical technology industry, particularly in regulatory affairs, will be considered a distinct advantage when assessing applications. Applications will be considered from candidates who hold a Level 7 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.

Graduates of this programme will demonstrate the ability to:

• Apply comprehensive regulatory knowledge and professional competence across complex, highly regulated environments
• Conduct advanced data analysis, critical evaluation, and accurate interpretation of scientific information
• Communicate complex scientific and technical data clearly and persuasively to diverse stakeholders, including regulators, healthcare professionals, internal teams, and the public
• Adapt effectively to changing regulatory frameworks and evolving medical technologies through strong problem-solving and decision-making skills
• Provide strategic, tactical, and operational support within multidisciplinary teams to ensure the timely development and delivery of compliant, safe, and effective products
• Exercise professional judgement in risk management, compliance planning, and regulatory strategy implementation
• Demonstrate leadership, organisational and project management skills in regulated industry settings
• Translate scientific evidence into practical, regulatory-compliant recommendations and solutions

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. 

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.

To find out more information on the course please contact medtech@universityofgalway.ie 

To apply for this programme please complete all of the steps below:

Step 1:  Ensure you are eligible—entry criteria

• Students with a Level 7 or higher qualification in Science or Engineering are eligible for the proposed Level 8 programme.
• Students with a Level 7 or higher qualification in a non-technical subject area but who hold a minimum of 5 years relevant medtech industrial experience in regulatory affairs or quality are eligible for the Level 8 programme.

Step 2:  Have all of the supporting documentation in place

Visit our Supporting Documents website for document requirements for this course.

Step 3: Ensure that you meet the English Language requirements

All applicants, whose first language is not English must present one of the following qualifications in the English language and have no less than 6.5 in ANY component. NOTE: Language tests must be undertaken no more than two years prior to commencement of your programme at the University.

Total Fees EU: €4,890

For 2026/27 entrants, where the course duration is greater than 1 year, there is an inflationary increase approved of 1.8% per annum for continuing years fees.