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Medical Technology Regulatory Affairs, M.Sc.

  • Application Deadline
  • 24 months
University rank #259 (QS) Online
The Medical Technology Regulatory Affairs programme at National University of Ireland, Galway is delivered online using a combination of distance-learning / e-learning technologies and face to face workshops for an overall blended learning approach. 


The Medical Technology Regulatory Affairs programme offered by National University of Ireland, Galway 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

Career Opportunities

This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs environment within the global Medical Technology industry sector. It has been specifically designed to meet the growing requirements of 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 in conjunction with a taskforce comprised of regulatory experts from industry and industry practitioners.

Programme Structure

Courses include
  •  EU Medical Device Regulatory Affairs 
  •  US Medical Device Regulatory Affairs 
  •  Technical Report Writing
  •  Global Medical Technology Regulatory Affairs Part 
  •  Clinical Evaluation
  •  Quality Management Systems
  •  Risk Management, Labelling and Promotion
  •  Medical Technology Regulatory Affairs DISSERTATION
  •  Design Assurance, Sterilisation and Biocompatability
  •  Post Market Surveillance

Detailed Programme Facts

  • Programme intensity Part-time
    • Average part-time duration 24 months
  • Credits
    90 ECTS
  • Languages
    • English
  • Delivery mode

English Language Requirements

  • Minimum required score:


    The IELTS – or the International English Language Test System – tests your English-language abilities (writing, listening, speaking, and reading) on a scale of 1.00–9.00. The minimum IELTS score requirement refers to which Overall Band Score you received, which is your combined average score. Read more about IELTS.

    Schedule IELTS
  • Minimum required score:


    The TOEFL iBT ® measures your English-language abilities in an academic setting. The test has four sections (reading, listening, speaking, and writing), each with a score range of 0-30, for a total score range of 0-120. Read more about TOEFL iBT ®.

    Schedule TOEFL®

Academic Requirements

You need the following GPA score:

Required score: Lower Second Class

Applicants for graduate programs must have the equivalent of a bachelor’s degree with a minimum GPA equivalent to Lower Second Class on the UK Honour scale. Admitted applicants typically have an undergraduate GPA of or better on the UK Honour scale. No exam grade should be lower than 4.5 (European grade scale) or D (American grade scale).

Your GPA (Grade Point Average) is calculated using the grades that you received in each course, and is determined by the points assigned to each grade (e.g. for the US grading scale from A-F).

General 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

Getting a Student Visa

This is an online programme. You can attend from the comfort of your chair! So you don't need a student visa!

Tuition Fee

  • International

    9000 EUR/year
    Tuition Fee
    Based on the original amount of 9000 EUR per year and a duration of 24 months.
  • EU/EEA

    6000 EUR/year
    Tuition Fee
    Based on the original amount of 6000 EUR per year and a duration of 24 months.
We've labeled the tuition fee that applies to you because we think you are from and prefer over other currencies.


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