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Code

SE91L

Location

Carlow

Campus

Kilkenny Road

  • Level Level 9
  • Duration 1-2 Years
  • Credits 90
  • Delivery Part-time
  • Applications Closing 30 Aug 2024
  • Fees View details
  • Application Status Open
  • Next Intake September 2024

Overview

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.

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

Duration

Please note that the course duration is two years for applicants who apply through PAC, and one year for applicants who apply through Springboard+.

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 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 Irelands 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.