Medical Technology Regulatory Affairs & Quality

Course Overview
Course Overview
The Level 8 Higher Diploma 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 Higher Diploma 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).

Regulatory Affairs and Quality personnel within the medical technology products sector are responsible for assuring that pertinent government obligations, market-driven demands, and evolving scientific conventions are understood and addressed by various stakeholders of the medical and healthcare system. Given the evolving nature of international regulations regulatory affairs and quality assurance professionals must continually grow their knowledge and skills to be effective and to advance in their careers. This course will ensure the development and enhancement of those skills.

The course will enable Regulatory Affairs and Quality Assurance personnel in the Medical Technology industry to understand all current device and diagnostic regulations and to develop the skills necessary to address and prepare for the ever-changing global environment of Regulatory Affairs and Quality Assurance. Upon successful completion of the programme, participants receive an NFQ Level 8 award of 30 credits. Upon successful completion of the programme, participants receive an NFQ Level 8 Higher Diploma award of 60 credits.

Course Outline
The Level 8 Higher Diploma in Medical Technology Regulatory Affairs and Quality is a two year part-time programme (60 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 12 modules, each worth 5 ECTS. The programme is delivered over four semesters (two academic years). Three modules are delivered per semester.

Assessment of students will be through continuous assessment of each module, which will include written assignments, workshop-based problem solving, and open-book exams using multiple choices, matching questions as well as short and long answer questions.

Year 1
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

Year 2
Semester 3 Modules (each module is 5 ECTS)
Fundamentals of Global Medical Device Regulations
Sterilisation & Biocompatibility
Operations Management. and GMP

Semester 4 Modules (each module is 5 ECTS)
Fundamentals of Medical Device Clinical Trials
Introduction to Market Vigilance & Labelling
Technical Report Writing

Year 1 (30 Credits)
Required MTR1101: Introduction to Quality Management Systems
Required MTR1102: Fundamentals of EU Medical Device Regulations
Required MTR1103: Auditing and Compliance
Required MTR1104: Fundamentals of US Medical Device Regulations
Required MTR1105: Risk Assessment
Required MTR1106: Validation and Calibration

Year 2 (30 Credits)
Required MTR1107: Fundamentals of Global Medical Device Regulations
Required MTR1108: Sterilisation and Biocompatibility
Required MTR1109: Operations Management & GMP
Required MTR1110: Fundamentals of Medical Device Clinical Trials
Required MTR1111: Introduction to Market Vigilance and Labelling
Required MTR1112: Technical Report Writing

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.

How to apply
We encourage all applicants to apply as early as possible.

Review/Closing Dates (for Taught Programmes)
For most programmes, University of Galway does not set specific closing dates for receipt of applications. Applications will be accepted on a rolling basis and course quotas will be reviewed continuously throughout the application cycle with the exception of applications for some programmes which are reviewed after the specified closing date. Candidates who do not have their final degree marks available may be made a conditional (provisional) offer.

Online Application
Applications to most postgraduate programmes at University of Galway are made online via www.universityofgalway.ie/apply (see "Application Weblink").

2 years, part-time, online distance learning (100% online).

Next start date: September 2024.

Review/Closing Dates (for Taught Programmes)
For most programmes, University of Galway does not set specific closing dates for receipt of applications. Applications will be accepted on a rolling basis and course quotas will be reviewed continuously throughout the application cycle with the exception of applications for some programmes which are reviewed after the specifed closing date*. Candidates who do not have their final degree marks available may be made a conditional (provisional) offer.

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.

Further Education
Following completion of the Higher Diploma (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 IT Sligo.