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
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.
Get more detailsVisit official programme website
Programme StructureCourses 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
- 24 months
Start dates & application deadlines
- Apply before
DisciplinesHuman Medicine View 16 other Masters in Human Medicine in Ireland
- 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
International9000 EUR/yearTuition FeeBased on the tuition of 9000 EUR per year during 24 months.
EU/EEA6000 EUR/yearTuition FeeBased on the tuition of 6000 EUR per year during 24 months.
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.
Apply and win up to €10000 to cover your tuition fees.
Due for update
Updated over a year ago
Check the official programme website for potential updates.