This programme has been designed to meet the growing requirements of Irish Medical Technology companies in filling regulatory and quality assurance roles. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed jointly by NUI Galway and IT Sligo in conjunction with an industry taskforce comprised of regulatory experts from IMDA’s Regulatory and Quality Working Group. The development of the programme is supported by the Irish Medical Devices Association Skillnet and contracting organisation, the Irish Medical Devices Association, the IBEC group that represents the Medical Technology sector. The IMDA skillnet will also support the participation of 15 students undertaking the MSc. degree programme.
The course will enable Regulatory Affairs personnel in the Medical Technology industry to understand all current device and diagnostic regulations and to develop the skills necessary to address and prepare for the ever-changing global environment of regulatory affairs. Upon successful completion of the programme, participants receive an MSc award at NFQ Level 9.
Programme objectives are:
- To produce graduates with the essential breadth and kind of knowledge, skills set and competencies required to function as a regulatory affairs professional in the medical device industry and to be capable of an immediate contribution to regulatory projects and projects with a regulatory element in a medical device company environment.
- To ensure that participants have sufficient skills and knowledge to employ appropriate advanced data analysing, synthesising, summarising and research skills in a regulatory environment.
- To ensure that participants can effectively communicate and defend scientific data and findings in a variety of forms to regulatory agencies, medical care systems, internal personnel and the public.
- To ensure participants have the skills and ability to function within, and adapt to, a changing technical work environment and evolving regulatory frameworks.
- To ensure the participants can provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to people around the world.
The programme consists of a two year part-time Level 9 MSc in Medical Technology Regulatory Affairs (90 credits). The programme shall be made available online using a combination of distance-learning / e-learning technologies and some face to face workshops for an overall blended learning approach. The educational elements will be provided by the Institute of Technology Sligo, and NUI Galway staff. Additional lecturing, as required, may be provided by outside specialists and practitioners.
The programme consists of 12 modules, each worth 5 ECTS. The programme is delivered over 2-2.5 years. Three modules are delivered per semester. A dissertation (30ECTS) is also carried out over year 1 and year 2.
Assessment of students will be through continuous assessment of each module, which will include written assignments, workshop-based problem solving, and open-book exams using multiple choices, matching questions as well as short and long answer questions. The Research Project thesis will also be assessed.
Applications are made online via IT Sligo admission: https://www.itsligo.ie/onlinelearning/apply/apply-to-it-sligo/
Key Course Information
Applications are made online via IT Sligo admission: https://www.itsligo.ie/onlinelearning/apply/apply-to-it-sligo/
Who teaches this course?
The programme will be delivered by academic staff from NUI Galway and It Sligo, with expertise in Regulatory Affairs, with guest lectures and workshops involving Regulatory Affairs experts from the Medical technology industry sector.
Find out more:
Prof. Terry Smith
T: 353 91 492 022
Ms Mary Butler
Institute of Technology, Sligo
Application Closing Date : 31st August 2020
Open to students who have obtained a Level 8 primary degree in a science/engineering subject related to the life sciences. Previous or current experience in regulatory affairs (minimum 2 years) may be taken into account in assessing entry qualifications for candidates with relevant Level 7 qualification with appropriate experience.
Candidates who have completed modules in cognate programme areas may also enter the programme and gain exemptions as determined by the Programme Committee in accordance with Institute’s guidelines. Cases will be assessed on an individual basis by the Programme Committee. Students applying on the basis of formal qualifications and supplementary accredited prior learning (APL) for core pre-requisites will be required to submit full details and references to the Programme Board for consideration of educational equivalencies. Prior experiential learning will be assessed using guidelines recommended by the Academic Council of IT Sligo and NUI Galway.
This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs environment within the highly successful and growing Irish Medical Technology industry sector.
The Irish Medical Devices Association (IMDA) states that the medical technology sector employs over 25,000 people, with 18 of the world’s top 25 medical technology companies maintaining a base in Ireland and a further 50% of the 300 Medtech companies being indigenous. The sector is expected to continue to grow as stated in December 2014 by the Director of the IMDA Sinead Keogh: "IMDA's latest survey shows that confidence within the sector is improving steadily…. with nearly half of companies more confident now than they were three months ago and nearly half planning to hire new staff.
Regulatory Affairs within the medical technology products sector is a relatively young, multidimensional profession that is international in scope. Operationally, a Regulatory Affairs professional is responsible for assuring that pertinent government obligations, market-driven demands, and evolving scientific conventions are understood and addressed by various stakeholders of the medical and health care system. Given the evolving nature of international regulations, a regulatory affairs professional must continually grow their knowledge and skills to be effective and to advance in their careers.
Regulatory professionals at all career and experience levels are involved in activities throughout the product lifecycle, and most are involved to some degree in bridging the gap between regulatory-related functions and organization and business activities.
Mark Fleming MANAGING DIRECTOR, FLEMING MEDICAL
Our participation in the Masters in Medical Technology Regulatory Affairs has allowed our company to enter several new major export markets so we can confidently deal with each specific international market’s regulatory requirement.
Dymphna Power | QUALITY AND REGULATORY MANAGER, FLEMING MEDICAL
The Masters is well worth pursuing, broadens knowledge with regard to regulatory compliance in European and Global markets.
Emily Kelly | HEALTHCARE PROFESSIONAL
The online MSc. in RA learning programme enabled me to gain a regulatory qualification, while balancing a full time job and a busy family life. Medical device manufacturers cannot work independently of RA. The course provided me with the knowledge and tools enabling me to make decisions from both a QM and RA perspective, taking into account every aspect of the medical device lifecycle from concept to post-market surveillance. In today’s market independent decision making can have severe repercussions for medical device manufacturers; this course provided the tools to navigate the regulatory landscape. The flexibility of on-line learning allowed for easy access to lectures, allowing completion of the course anywhere. Classes were interactive and the periodic workshops allowed for good interaction and team building among the group. Lecturers were very knowledgeable and helpful, providing constructive feedback on the application of the course material.
Brian Cullinan | DIRECTOR QA/RA, SIEMENS HEALTHCARE DIAGNOSTICS
The regulatory environment is becoming increasingly complex and interconnected. Whilst regulations are harmonising, interpretation and implementation remain challenging. At Siemens Healthineers our QA/Regulatory professionals need to regularly refresh their knowledge as regulations evolve. The Masters in Medical Technology Regulatory Affairs provides a framework not only for acquiring the knowledge but also for building the expertise required to apply that knowledge practically and effectively. It’s the start of a career long learning experience, which enables us to develop world class regulatory professionals.
Aine Foley – Senior Regulatory Affairs Specialist at Teleflex Incorporated stated;
“I have been able to bring so much of what I learned to my day to day work. I also think it has had a positive impact on the company I worked for, as I was able to share my knowledge and work to build a better system. I would not have been able to progress to Senior role so quickly, without the Masters”.
“The MSc Medtech programme has been extremely useful as it is flexible, directly relevant and my fellow colleagues are professionals with extensive medical device experience who are always happy to help or provide a perspective.”
Jacques du Preez (International student)
“The MSc Medtech RA programme provides up-to-date and highly relevant regulatory insights. It will help me in my personal development and my organisation to meet future challenges.”
Michael Sander (International student)
Vice President Operations.
mdi Europa GmbH
Langenhagener Str. 71
“I finished my Masters of Science in Medical Technology Regulatory Affairs this year (2018). I work in Regulatory Affairs/Vigilance at Medtronic, and this course provided me with a deep knowledge and understanding of a wide range of Regulatory Affairs topics, which were both relevant and interesting. The course provides a variety of learning applications such as live lectures, workshops, assignments and weekly activities which enable students to obtain a comprehensive understanding of the regulatory environment. Continuous assessments throughout the course provides excellent feedback on your level of comprehension and the status of your learning. Meeting tutors and fellow students at the workshops is an excellent way of sharing ideas, knowledge and getting expert advice and support. For my thesis, I chose a topic that I really knew very little about and although it was a steep learning curve and there were many hurdles and challenges along the way, it provided me with an in-depth knowledge of the subject and a great sense of achievement. I have used the knowledge that I have gained from my Masters in my work on many occasions, and have provided guidance and advice relating to regulatory requests and issues to other colleagues, when needed. Based on my achievement, I have also been promoted in my job to Regulatory Affairs Supervisor which I could not have achieved without this qualification. I would have no hesitation in recommending this course to any student who would like to gain more knowledge relating to medical device regulation and would like to progress in their career”.
Senior Regulatory Affairs Supervisor |Regulatory Affairs
IDA Business & Technology Park,
Tullamore, Co. Offaly, Ireland
Office 353-(0)57 93-27231
'As a regulatory affairs professional I was interested in having a recognised qualification in my area of expertise. I enjoyed the two intensive years studying the MSc in Medical Technology Regulatory Affairs program. It enhanced my regulatory knowledge and the assignments were reflective of the day to day work in regulatory affairs.
As well as enhancing my technical knowledge I developed a network of regulatory affairs professionals. While studying I had the opportunity to progress into management. I know the skills and knowledge I gained while studying really helped me in management role.'
Regulatory Affairs Manager,
“The MSc Medtech Regulatory Affairs programme has provided me the right information and tools to understand and interpret the various global medical device regulations and use the gained knowledge in my daily job.”
“ International Student - Philips / QMS Manager “
“The MSc degree is invaluable in terms of quantifying and putting a structure around the profession of Regulatory Affairs. Having worked in Industry for many years it was difficult to quantify experience gained. The academic acknowledgement of completing the MSc provides a transparency and bench marks a combination of experience and the course work to complete the MSc degree. The MSc has helped structure learning that can be applied to everyday eventualities in the ever changing, fast paced, Regulatory Affairs space. The course has also provided a network of trusted peers where you can share your experience and elicit advice, something that would not have been the done thing in industry prior to this. While the course is intense, being able to attend lectures online from home and the combination of semester workshops works very well for full time professionals who are juggling many other conflicting priorities. The MSc has already provided career development for me with a promotion and I don’t doubt that it has opened up many more opportunities in this field of work. In the coming years of tighter regulation globally, I would recommend this MSc as a platform for the profession.”
Principal Regional RA Specialist,
Did you know?
EU students: MSc €12,000. Individual modules €900. Dissertation €2500.
Non EU fees: €18,000 for MSc
Anyone living / working outside of Ireland and the EU for over 3 years pays non-EU Fees
|EU Medical Technology Regulatory Affairs – Introduction||5|
|US Medical Technology Regulatory Affairs- Introduction||5|
|Technical Report Writing||5|
|Global Medical Technology Regulatory Affairs Introduction||5|
|Quality Management System||5|
|EU Medical Technology Regulatory Affairs – Advanced||5|
|US Medical Technology Regulatory Affairs- Advanced||5|
|Risk Management, Labelling & Promotion||5|
|Global Medical Technology Regulatory Affairs – Advanced||5|
|Design Assurance, Sterilisation and Biocompatability||5|
|Post Market Surveillance||5|