Medical Technology Regulatory Affairs & Quality

Course Overview

The Level 8 Certificate in Medical Technologies Regulatory Affairs and Quality provides students with an introduction to the core elements of the product development lifecycle and the associated role of a Medical Technology Regulatory Affairs and/or Quality professional. The programme ensures that students acquire a good, fundamental understanding of all applicable regulations and skills to address the ever-changing environment of Medical Technologies Regulatory Affairs and Quality.



The Level 8 Certificate 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 IT 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).

Course Outline

The Level 8 Certificate in Medical Technology Regulatory Affairs and Quality is a one year part-time programme (30 credits). The programme is made available online using a combination of distance-learning / e-learning technologies, with some optional workshops. The educational elements are provided by University of Galway and Institute of Technology Sligo staff. Additional lecturing, as required, may be provided by industry specialists and practitioners.



The programme consists of six modules, each worth 5 ECTS. The programme is delivered over two semesters (one academic year). Three modules are delivered per semester.



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



The Certificate programme is also available for students to undertake in a modular format, enabling students to select any individual module or combination of modules in any year, up to a maximum of 3 modules per semester



Students undertaking the modular programme can select any individual module or combination of modules from the six modules in one year. Students must complete all 6 modules within six years, to obtain a Level 8 certificate award.



The programme is being made available online using a combination of distance-learning/e-learning technologies and some face-to- face workshops for an overall blended learning approach. The educational elements is provided by the Institute of Technology, Sligo, and University of Galway staff. Additional lecturing, as required, may be provided by industry specialists and practitioners.



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

Curriculum Information

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



Year 1 (30 Credits)

RequiredMTR1105: Risk Assessment

RequiredMTR1102: Fundamentals of EU Medical Device Regulations

RequiredMTR1103: Auditing and Compliance

RequiredMTR1101: Introduction to Quality Management Systems

RequiredMTR1106: Validation and Calibration

RequiredMTR1104: Fundamentals of US Medical Device Regulations

Students with a Level 7 or higher qualification in science or engineering are eligible for this Level 8 programme. Students with a Level 7 or higher qualification in a non-technical subject area but who hold a minimum of two years’ relevant medtech industrial experience in regulatory affairs or quality are also eligible to apply.

Applications must be completed online at: https://nuigalway.elluciancrmrecruit.com/Apply/Account/Login.



An application requires a registration fee of €35. You will be asked to upload proof of identification, academic transcripts, a personal statement, an academic reference and documentation to fulfil the English requirement (where English is not your first language).

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

Next start date September 2025



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.