Programme Aims
The programme aims to provide participants with a strong foundation in medical device regulatory and quality requirements and the training needed to transition life science graduates into specialist roles in regulatory affairs and quality assurance, while also upskilling existing professionals. It develops essential skills in data analysis, synthesis, summarising and technical writing within a regulatory context, and fosters the ability to communicate effectively across a range of media. Participants will gain the knowledge and adaptability required to operate within a rapidly evolving technical and regulatory environment, enabling them to support compliance and contribute to the safe and efficient development of healthcare products globally.

The programme equips regulatory and quality professionals in the medical technology industry with a comprehensive understanding of current device and diagnostic regulations and the skills required to respond to the continuously changing global regulatory landscape. Upon successful completion, participants receive an NFQ Level 8 award of 60 credits, with the full Higher Diploma awarded at NFQ Level 8 for 60 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 Higher Diploma in Medical Technology Regulatory Affairs and Quality is a two-year, part-time programme worth 60 ECTS. 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 twelve modules, with three delivered per semester. Students must successfully complete all twelve modules to obtain the Level 8 Higher Diploma 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.

Year 1 
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 

Year 2 
Semester 3 Modules (each module is 5 ECTS)

1. Fundamentals of Global Medical Device Regulations
2. Sterilisation & Biocompatability
3. Operations Management. and GMP 

Semester 4 Modules (each module is 5 ECTS)

1. Fundamentals of Medical Device Clinical Trials
2. Introduction to Market Vigilance & Labelling
3. Technical Report Writing

• Industry-driven design – Developed in direct response to MedTech industry needs, guided by a specialist taskforce of regulatory experts and practitioners.
• Strong career focus – Specifically prepares graduates for Regulatory Affairs, Quality Assurance and Operations roles within Ireland’s fast-growing MedTech sector.
• Alignment with national skills strategy – Informed by Irish Medtech Association and Skillnet workforce analysis addressing recognised skills gaps.
• Specialist regulatory expertise – Delivered with input from experienced industry professionals ensuring real-world, up-to-date regulatory knowledge.
• High employability relevance – Targets high-growth areas including a 43% projected increase in regulatory affairs roles.
• Future-ready skills – Equips learners to operate within evolving regulatory and compliance environments in medical technology.

Graduates of this programme are well positioned to pursue specialist careers within the medical technology sector, particularly in Regulatory Affairs and Quality Assurance functions.

The course enables participants, including those transitioning from life sciences backgrounds or upskilling within existing roles, to move into positions such as Regulatory Affairs Specialist, Quality Assurance Specialist, Compliance Officer, Regulatory Project Coordinator, and Medical Device Regulatory Associate. With strong grounding in regulatory frameworks, data analysis, and scientific communication, graduates are equipped to contribute effectively to regulatory-driven projects, support product development and compliance processes, and work collaboratively with regulatory authorities and healthcare stakeholders.

The adaptable skillset developed through the programme also prepares graduates to operate confidently in evolving technical and regulatory environments, supporting the delivery of safe and effective medical technologies to global markets.

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

The programmes 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 with some optional workshops. 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 two-year Higher Diploma in Medical Technology Regulatory Affairs and Quality (60 credits) students are 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.

Send transcripts and Updated CV to medtech@universityofgalway.ie

Total Fees EU: €4,500

For information on possible fee support available visit Next Level Skillnet - Transforming Business Through Talent