Studyportals

Medical Technology Regulatory Affairs

National University of Ireland, Galway

M.Sc. Online
24 months
Duration
9000 EUR/year
6000 EUR/year
Unknown
Tuition fee
Unknown
Apply date
Unknown
Start date

About

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. 

Overview

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

Key information

Duration

  • Part-time
    • 24 months

Start dates & application deadlines

Language

English

Credits

90 ECTS

Delivered

Online

Academic requirements

GPA admission requirements GPA Your GPA, or Grade Point Average, is a number that indicates how well or how high you scored in your courses on average. Usually a GPA scales between 1.0 and 4.0, however different countries and universities can have different grading systems.
Lower Second Class

English requirements

TOEFL admission requirements TOEFL® IBT The TOEFL iBT® is given online through the internet at designated testing site. The test measures your English-language abilities in an academic setting. The score refers to the total score of 4 subjects (writing, listening, speaking, and reading), each subject has a range of 0 - 30.
88
IELTS admission requirements IELTS The International English Language Test System (IELTS) tests your English-language proficiency on a scale of 1 – 9. The score refers to the combined average score of 4 subjects (writing, listening, speaking, and reading).
6.5

Other requirements

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

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.

Funding

Studyportals Tip: Students can search online for independent or external scholarships that can help fund their studies. Check the scholarships to see whether you are eligible to apply. Many scholarships are either merit-based or needs-based.

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!

Our partners

Medical Technology Regulatory Affairs
-
National University of Ireland, Galway

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