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Medical Technology Regulatory Affairs (MSc)

 

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Course Overview

About the Programme

 The programme is offered as a two year part-time Level 9 MSc in Medical Technology Regulatory Affairs (90 credits). The programme is delivered online using a combination of distance-learning / e-learning technologies and face to face workshops for an overall blended learning approach. The programme consists of 12 modules, each worth 5 ECTS. Three modules are delivered per semester. A dissertation (30ECTS) is also carried out over Year 1 and year 2.  Assessment of students is through continuous assessment

The MSc programme is also available for students to undertake in a modular format. Students undertaking the modular programme can select any individual module or combination of modules in any year, up to a maximum of 3 modules per semester.  Students must complete all 12 taught modules and a research project within six years, to obtain an MSc degree.  Postgraduate Certificate and Diplomas are also available as exit degrees, based on the completion of 6 or 12 taught modules.  

 Programme objectives are to:

  • Produce graduates with the essential breadth and knowledge, skills and competencies required to work as a regulatory affairs professional in the Medical Technologies industry sector
  • Provide participants with professional skills and knowledge to conduct appropriate advanced data analysis and interpretation in a highly regulated environment
  • Enable participants to effectively communicate and defend scientific data and findings in a variety of forms to regulatory agencies, medical care systems, internal personnel and the public
  • Provide participants with the skills and ability to function within, and adapt to, a changing medical technologies environment with rapidly evolving regulatory frameworks
  • Prepare participants to provide strategic, tactical and operational direction and support to expedite the development and delivery of safe and effective healthcare products to the required regulatory standards

Applications and Selections

Applications are made online via The Postgraduate Applications Centre (PAC). 

In order to apply for this programme please complete all of the steps below:

Step 1:  Ensure you are eligible—entry criteria

  • Candidates should hold at least a Second Class Honours Level 8 primary degree in a relevant subject area in science or engineering
  • Prior medical technology industry experience in regulatory affairs will be considered a distinct advantage in assessing applications
  • Applications from candidates who hold a Second Class Honours Level 8 primary degree in a non-technical subject, and who have at least five years medical technology industry experience in quality and/or regulatory affairs will be considered
  • Applications will also be considered from candidates who hold a degree in a relevant subject area in science or engineering at Level 7, with at least two years’ medical technology industry experience in quality and/or regulatory affairs 
  • Candidate interviews may be used to assess candidates’ suitability for the programme
  • International students, whose first language is not English, will be required to prove their English competency through their school leaving examination or matriculation examination or by achieving the minimum standard in a recognised English language test

Step 2:  Have all of the supporting documentation in place

Visit our Supporting Documents website for document requirements for this course.

Step 3: Ensure that you meet the English Language requirements

All applicants, whose first language is not English must present one of the following qualifications in the English language and have no less than 6.5 in ANY component. NOTE: Language tests must be undertaken no more than two years prior to commencement of your programme at the University.

IELTS

TOEFL

Pearson PTE

6.5

88

61

6.5

88

61

6.5

88

61

 The NUI Galway TOEFL institution code is 8861.

Any PAC application queries should be emailed to postgradadmissions@nuigalway.ie 

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. 

View programme team information here.

Requirements and Assessment

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. 

Key Facts

Entry Requirements

  • Candidates should hold at least a Second Class Honours Level 8 primary degree in a relevant subject area in science or engineering
  • Prior medical technology industry experience in regulatory affairs will be considered a distinct advantage in assessing applications
  • Applications from candidates who hold a Second Class Honours Level 8 primary degree in a non-technical subject, and who have at least five years medical technology industry experience in quality and/or regulatory affairs will be considered
  • Applications will also be considered from candidates who hold a degree in a relevant subject area in science or engineering at Level 7, with at least two years’ medical technology industry experience in quality and/or regulatory affairs 
  • Candidate interviews may be used to assess candidates’ suitability for the programme
  • International students, whose first language is not English, will be required to prove their English competency through their school leaving examination or matriculation examination or by achieving the minimum standard in a recognised English language test

Additional Requirements

Duration

2 years part-time

Next start date

September 2018

A Level Grades ()

Average intake

25

Closing Date

15 August 2018

Next start date

September 2018

NFQ level

9

Mode of study

Taught

ECTS weighting

90

Award

CAO

PAC code

GYS30 (part-time); GYS29 (part-time, modular)

Course Outline

  • The programme is offered as a two year part-time Level 9 MSc in Medical Technology Regulatory Affairs (90 credits)
  • The MSc. programme is also available for students to undertake in a modular format, enabling students to select any individual module or combination of modules in any year, up to a maximum of 3 modules per semester
  •  The module programme offering gives students the option to complete all 12 taught modules and a research project within six years to obtain an MSc. degree
  •  Post-graduate Certificate and Diploma awards are also available, based on the completion of 6 or 12 taught modules

The programme is being 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 is 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 of 5 ECTS, delivered over 2 Years (6 modules per year), and a research Project (30 ECTS), carried out over both years of the programme.

Programme modules

Full list of modules, and their detail is online here.

Why Choose This Course?

Career Opportunities

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 organisation and business activities.  

Who’s Suited to This Course

Learning Outcomes

 

Work Placement

Study Abroad

Related Student Organisations

Course Fees

Fees: EU

€6,000 p.a. 2016/17

Fees: Tuition

€5,944 p.a. 2016/17

Fees: Student levy

€56 p.a. 2016/17

Fees: Non EU

€13,750 p.a. 2016/17

Fees: Modular

GYS29 (part-time, modular)
Individual taught modules (up to 12 modules): €900 per module
Fee for research dissertation: €2,700

For more information please go to www.mscregaffairs.ie

For further information on postgraduate funding & scholarship opportunities please see here.

Find out More

Course Director:
Prof. Terry Smith

 

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T: +353 91 492 022
E: terry.smith@nuigalway.ie

Course Director: 
Ms Mary Butler   

  

‌

Institute of Technology, Sligo

E: butler.mary@itsligo.ie

 

www.mscregaffairs.ie

View programme team information here.

What Our Students and Employers Say

Mark

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

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

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

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.

 

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