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Medical Device Regulatory Affairs

This Master of Science course in Medical Device Regulatory Affairs presents students with the opportunity to obtain a formal qualification in the medical device regulatory industry.

This course will provide learners with increased skills and competencies for career progression within a rapidly growing global industry sector in which Ireland is a key location for many of the global medtech industry leaders.

The course presents a broad view of the regulatory affairs role and 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.

Exit Award - Yes.

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 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.

Duration

1 Year Full-time, 2 Years Full-time.

Careers or 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. 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'.

Further enquiries

Joseph Collins BA, HDipEd, STB, MEd, STL
Head of Faculty, Lifelong Learning
P: 059 917 5280
E: LLL@itcarlow.ie

Subjects taught

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 Course Management, Vigilance Surveillance and Risk Management
Clinical Evaluation of Medical Device Technologies

Comment

Postgraduate Opportunities - Institute of Technology Carlow. Institute of Technology Carlow has a range of high-quality courses that offer suitably qualified primary degree holders (NFQ Level 8) exciting opportunities to progress to higher awards (Masters and Doctoral degrees). These opportunities are by research and thesis or taught courses, with many available on a full-time or part-time basis across our three campuses in Carlow, Wicklow and Wexford.

Higher Degrees by research are normally obtained by undertaking a research project, guided by an experienced supervisor. The average duration of a research Masters degree (NFQ Level 9) is 2 years full-time study. A PhD (NFQ Level 10) should take from 3 to 4 years (full-time) to complete.

Taught courses are available at three levels: Higher Diploma (NFQ Level 8); Postgraduate Diploma - NFQ Level 9 (60 credits); and Masters - NFQ Level 9 (90 credits). Individual full-time postgraduate courses are described in the forthcoming sections. Details of part-time taught courses are available in the Lifelong Learning prospectus.

Research Masters and Doctoral Degrees
Institute of Technology Carlow offers postgraduate research supervision for both Research Masters and Doctoral Degree candidates (NFQ Levels 9 and 10). Research supervision is closely tied to the priorities and expertise of staff attached to specialist research centres at Institute of Technology Carlow. Research, Development and Innovation (RDI) is an integral part of Institute of Technology Carlow's activities and a vital aspect of its interaction with industry and other research centres, both nationally and internationally.

Application date

How to apply
1. Research & choose your course from our wide range of postgraduate offerings on our website or in our prospectus.

2. Check out all of the relevant entry requirements, course code and closing dates, taking time to read IT Carlows FAQs and application instructions on the Admissions section of the website.

3. Get started on your postgraduate journey at IT Carlow!

For admissions queries from Irish or European applicants, please email: graduatestudies@itcarlow.ie.

All Non-EU international applicants may refer to the International section of the website for further details or email: international@itcarlow.ie.

Course fee

This course is not eligible for Free Fees. Programme Fees 2017/18 €7,400. Fees under review for 2018/19.

Enrolment and start dates

Postgraduate application procedure
Postgraduate applicants should refer to the Study/Postgraduate section of the website for more information: www.itcarlow.ie/study/postgraduate-rd.

Remember to mention gradireland when contacting institutions!