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About Master Of Science In Medical Device Regulatory Affairs in Institute of Technology Carlow

This Master of Science in Medical Device Regulatory Affairs presents students with the opportunity to skills to employers and peers, and to enhance your career in regulatory affairs by developing increasing levels of competence and professionalism. It is the ‘gold standard’ in the field.

Students will gain invaluable access obtain a formal qualification in the medical device regulation industry. The programme presents a broad view of the regulatory affairs role  and provides a detailed insight into current and proposed EU legislation. It provides students with an advanced theoretical understanding of the processes and practices central to medical device regulatory affairs.

The medical device sector is highly diverse. It covers thousands of products – from simple bandages and spectacles, through implantable devices, equipment for screening, to the most sophisticated diagnostic imaging and minimally invasive surgical equipment. Strong growth prospects for the industry globally are driven by ageing populations, increase in chronic ailments and increasing consumer wealth driving demand in emerging economies.

A formal qualification is the ideal way to demonstrate your existing to industry professionals and networking events to help develop their careers. There are limited places available on this programme – class sizes are kept relatively small to help create an interactive environment and to ensure each student receives excellent support from our academic team.

What will I be able to do when I finish this programme?

This MSc will allow students to develop a set of transferable  skills that will directly meet the requirements of future  employers including information technology, written and verbal communication skills, team working, independent research skills, data analysis and critical thinking.

What subjects will I study?

• Regulatory Affairs Quality Management and Strategy
• Research Methods and Technical Report Writing
• Medical Device Technologies: Design, Development and Testing
• Medical Technology Regulatory Affairs
• Product Programme Management, Vigilance, Surveillance and Risk Management
• Clinical Evaluation of Medical Device Technologies

Study Opportunities

Opportunities for graduates from this programme include progression to Level 10 (PhD) programmes in related fields of study.

Potential employment opportunities

This MSc provides graduates with an advanced theoretical understanding of the processes and practices central to medical device regulatory affairs. Graduates can move into regulation roles and/or be promoted within their organisation.

Ireland is one of the leading global medical devices industry centres. There is a very strong multinational presence in the sector with many of the top medical devices and related global companies basing in Ireland.

The medical devices sector also links in strongly with the ICT and engineering base, for example as key partners in delivering healthcare solutions (Nypro, HP, IBM, Analog and Intel). In its 2013 report, the Expert Group on Future Skills Needs (EGFSN, 2013)  reported  on requirements of the Manufacturing sector to 2020, in which they predict employment to continue to increase by 43,000 by 2020.

The report included the Medical Devices sector as one of the subsectors driving this demand. The Irish Medical Devices Association (IMDA) represents over 170 organisations in Ireland and works with government and policy makers nationally and internationally to drive economic growth in the sector. According to the IMDA, there is now a shift in consumer technology companies making inroads into medicine and Ireland is uniquely placed to harness and leverage the opportunity between these industries. According to a medical devices regulatory affairs manager consulted as part of the development of the proposed programme, ‘all major medical device multinational companies now have sites in Ireland and there is a major need for graduates to support the sector who have an expertise in regulatory affairs’.

Academic qualification equivalents

• Applicants should have an honours degree in a related subject.

English language requirements (one of the below):

• IELTS: 6.0 IELTS(minimum of 5.5 IELTS in each component)
• TOEFL: iBT 90 , CBT 232 , PBT 575
• PTE: 58 - 64

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