Overview
This programme presents a broadview 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.
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
- Research Dissertation
Entry Requirements
Applicants require a second class honours degree or higher, or an equivalent in a science, business or management subject. Other applicants will be considered on an individual basis in accordance with the University policy on Recognition of Prior Learning (RPL). SETU Carlow reserves the right to require applicants to attend for an interview to determine their suitability for the programme.
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 globalmedical devices industry centres. Themedical technology (medtech) sectoremploys over 29,000 people in Irelandand is the second largest employer ofmedtech professionals in Europe.
There is a very strong multinationalpresence in the sector with many ofthe top medical devices and relatedglobal companies based in Ireland.Exports of medical devices anddiagnostic products now represent 8%of Irelands total merchandise exports.The medical devices sector also links instrongly with the ICT and engineeringbase, for example as key partners indelivering healthcare solutions (Nypro,HP, IBM, Analog and Intel). Accordingto the IMDA, there is now a shift inconsumer technology companiesmaking inroads into medicine andIreland is uniquely placed to harnessand leverage the opportunity betweenthese industries.
According to a medical devicesregulatory affairs manager consultedas part of the development of theproposed programme, all majormedical device multinationalcompanies now have sites in Irelandand there is a major need for graduatesto support the sector who have anexpertise in regulatory affairs.