Medical Device Regulatory Affairs
What is the programme about?
This 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.
Students who successfully complete the relevant 60 credits of the programme will be eligible for the Postgraduate Diploma in Medical Device Regulatory Affairs (Level 9) should they opt to leave the programme (Embedded Exit Award).
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 Institute policy on Recognition of Prior Learning (RPL). IT Carlow reserves the right to require applicants to attend for an interview to determine their suitability for the programme.
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
CWL13 Master of Science in Medical Device Regulatory Affairs CARLOW Part-time NFQ Level 9 Credits 90
CWL14 Postgraduate Diploma Medical Device Regulatory Affairs CARLOW Part-time NFQ Level 9 Credits 60
Carlow - 2 years part-time.
CWL13 Master of Science in Medical Device Regulatory Affairs CARLOW Part-time €7,400*
CWL14 Postgraduate Diploma Medical Device Regulatory Affairs CARLOW Part-time €5,500
*Fees for ITC Major Award graduates only – €5,500.
Post Course Info
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 follow-on study opportunities are available?
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'.