Medical Device Regulatory Affairs - Carlow / Wicklow
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.
| Award Name | Postgraduate Diploma (Level 9 NFQ) |
|---|---|
| NFQ Classification | Major |
| Awarding Body | South East Technological University |
| NFQ Level | Level 9 NFQ |
| Award Name | Degree - Masters (Level 9 NFQ) |
| NFQ Classification | Major |
| Awarding Body | South East Technological University |
| NFQ Level | Level 9 NFQ |
| Award Name | NFQ Classification | Awarding Body | NFQ Level |
|---|---|---|---|
| Postgraduate Diploma (Level 9 NFQ) | Major | South East Technological University | Level 9 NFQ |
| Degree - Masters (Level 9 NFQ) | Major | South East Technological University | Level 9 NFQ |
Duration
1 Year Full-time/2 Years Part-time
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.
Careers / Further progression
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. The medical technology (medtech) sector employs over 29,000 people in Ireland and is the second largest employer of medtech professionals in Europe.
There is a very strong multinational presence in the sector with many of the top medical devices and related global companies based in Ireland. Exports of medical devices and diagnostic products now represent 8% of Ireland’s total merchandise exports. 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). 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’.
Further information
SE91P Master of Science in Medical Device Regulatory Affairs CARLOW Full-time €7,400
SE91L Master of Science in Medical Device Regulatory Affairs CARLOW Part-time €7,400
SE91M Postgraduate Diploma Medical Device Regulatory Affairs CARLOW Part-time €5,500
Course Codes:
SE91P Master of Science in Medical Device Regulatory Affairs CARLOW Full-time
SE91L Master of Science in Medical Device Regulatory Affairs CARLOW Part-time
SE91M Postgraduate Diploma Medical Device Regulatory Affairs CARLOW Part-time
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
Exit award: Postgraduate Diploma in Science in Medical Device Regulatory Affairs (Level 9 - 60 credits).
Eoin O'Brien
BA, DBS, CBS, Cert Mgmt, MBA
Faculty of Lifelong Learning Manager
E: eoin.obrien@setu.ie