The Level 8 Certificate in Medical Technologies Regulatory Affairs and Operations 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 Operations 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. Fundamentals of Global Medical Device Regulations.
2. Sterilisation & Biocompatability.
3. Operations Management and GMP.

Semester 2 Modules (each module is 5 ECTS)

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

Curriculum Information

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

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

Please note to be eligible to apply you need:

• Candidates should hold at least a Level 7 primary degree in a relevant subject area in science or engineering
• 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.
• Students applying on the basis of formal qualifications and supplementary accredited prior learning (APL) for core pre-requisites will be required to submit full details and references to the Programme Board for consideration of educational equivalencies. Prior experiential learning will be assessed using guidelines recommended by the Academic Council of ATU Sligo and University of Galway.
• All applicants, whose first language is not English must present a qualification in the English language e.g. IELTS (no less than 6.5 in ANY component); TOEFL ((no less than 88 in ANY component); and Pearson (no less than 61 in ANY component). NOTE: Language tests must be undertaken no more than two years prior to commencement of your programme at the University.
• English Language Entry Requirements (replace/edit the text below)
• For applicants whose first language is not English, an English language proficiency of IELTS score of 6.5 is required (with no less than 6.5 in Writing and no less than 6.0 in any other band) or equivalent. 

To apply for the Certificate through Springboard please go to Springboard Courses

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 five 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.

*The University of Galway TOEFL institution code is 8861.

Any application queries should be emailed to medtech@universityofgalway.ie 

Fees for Academic Year 2026/27

Through Springboard+ funding, employed candidates only pay €370 to study this course. For unemployed candidates, the course tuition fee is free, with 100% of the fee funded by Springboard+. Next Level Skillnet funding may also be available to successful applicants who fulfil eligibility criteria

Fees
The Level 8 Certificate is approved as a HEA Springboard course.

To apply for the Certificate through Springboard please go to Springboardcourses.ie

Total Fees EU: €4,500

Through Springboard+ funding, employed candidates only pay €370 to study this course. For unemployed candidates, the course tuition fee is free, with 100% of the fee funded by Springboard+. Next Level Skillnet funding may also be available to successful applicants who fulfil eligibility criteria