Program Overview

Course Overview

The Level 8 Certificate in Medical Technologies Regulatory Affairs and Operations has been specifically designed to meet the growing requirements of medical technology companies in filling regulatory and quality assurance roles, introducing a focus on operations. The course links the existing regulations to regulatory requirements and how those requirements are executed across the medical device lifecycle.

Programme Aims

• Provide participants with a fundamental grounding in medical device regulatory structures and requirements.
• Provide the training necessary to convert personnel employed in the Medical Technologies sector with life sciences qualifications to transition into specialist roles in the medical technology quality assurance and/or regulatory affairs functions and to upskill medical technology professionals in the regulatory framework in their existing roles.
• Foster the participant's intellectual development in academic and industrial environments.
• Develop participant's skills to work and communicate with appropriate autonomy and effectively through various media.

Programme Objectives

• To produce graduates with the essential breadth and kind of knowledge, skills set and competencies required to function in specialist roles in the medical technology regulatory affairs function, to upskill medical technology professionals in the regulatory framework in their existing roles and to be capable of contribution to regulatory projects and projects with a regulatory element in a medical device company environment.
• To ensure that participants have sufficient skills and knowledge to employ a fundamental level of data analysing, synthesising, summarising and writing skills in a regulatory environment.
• To ensure that participants can communicate and defend scientific data and findings in a variety of forms to regulatory agencies, medical care systems, internal personnel and the public.
• To ensure participants have the skills and ability to function within, and adapt to, a changing technical work environment and evolving regulatory frameworks.
• To ensure the participants can provide appropriate input and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to people around the world.

Entry Requirements

• Graduates with a level 7 qualification or higher 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.
• 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).

Course Outline

The Level 8 Certificate in Medical Technology Regulatory Affairs and Operations programme is a one year part-time 30 ECTS course, delivered over two Semesters from September-May each year. The programme is made available online using distance-learning / e-learning technologies, with one optional workshop.

Semester 1 Modules

• Fundamentals of Global Medical Device Regulations
• Sterilisation & Biocompatability
• Operations Management and GMP

Semester 2 Modules

• Fundamentals of Medical Device Clinical Trials
• Introduction to Market Vigilance & Labelling
• Technical Report Writing

Assessment

Assessment of students is through continuous assessment of each module, including written assignments, e-tivities, problem solving, and online open-book exams using multiple choices, matching questions as well as short and long answer questions.

Career Opportunities

This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs or Quality environment within the highly successful and growing Irish Medical Technology industry sector.

Fees

• Fees: EU - 4,500 p.a. 2025/26
• Fees: Tuition - 4,500 p.a. 2025/26
• Fees: Student levy - 0
• Fees: Non EU - Not specified

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