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Quality & Regulatory Affairs- BSc

Course Details

Award: Bachelor of Science (BSc.)
Qualification: Undergraduate NFQ Level 8 Delivery:
Blended & Online
3 semesters
On- campus classes 4 to 6 Saturdays of the semester
Start Date: September 2020 Enquiries:

The Bachelors in Science in Quality and Regulatory affairs – run in conjunction with the Irish MedTech Association, is certified by University of Limerick. 

This is a top-up degree for persons who already hold an NFQ Level 7 (ordinary) degree (180 ects) plus 3 years of relevant work experience. It is designed specifically by the medical technology companies to reskill or upskill existing employees to take up roles in the quality and regulatory affairs function that now require a level 8 qualification. It is also suitable for unemployed persons that meet the entry requirements. The BSc in Quality and Regulatory Affairs is a distance education course with 12 days classroom time over the 12 months.

This is an accelerated course which starts in September, and runs through until the following August. 

For those who have a level 7 qualification and wish to top up to a level 8 Degree award. For those who work in the following sectors: design, manufacture of medical device technology, pharma/biopharma, and certain elements of the software and electronics industry.

It is expected that applicants have work experience in, at least one of, the design, production, quality, regulation, compliance and or validation functions.

This programme is a level 7 to level 8 top-up programme. Those holding a Level 8 major award of an honours degree are not eligible to apply for this programme.

Applicants should have a NFQ Level 7 (ordinary) degree (180 ects) in a Science, Technology, Engineering, and Mathematics (STEM) discipline.

Applicants should have 3 years work experience in a regulated sector.

Applicants education qualifications, work experience; particularly in regulation, validation and compliance, their motivation and overall potential to be successful on the programme will be considered in evaluating an application.

Applicants are required to meet the University of Limerick English Language requirements.


Semester 1 Autumn 

  • Introduction to Quality Management (6 ects.)
  • Quality Science (6 ects.)
  • Problem Solving Tools & Techniques (6 ects.)



Semester 2 Spring 

  • Medical Device Science (6 ects.)
  • Bio Compatibility & Device Design (6 ects.)
  • Fundamentals in Regulatory Affairs (9 ects.)

Semester 3 Summer 

  • Validation Principles & Practices (9 ects.)
  • Project (12 ects.)
  • Option: Career Development Programme

There will be approx 13 Saturdays of face-to-face learning plus online learning throughout the years programme.

Start Date: TBC
End Date: TBC

Semester 1 4 x Saturdays classroom
Semester 2 6 Saturdays classroom
Semesters 3 3 Saturdays classroom


For more information on programme fees, contact the Irish MedTech Association


For more information on applications, contact the Irish MedTech Association