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Quality and Regulatory Affairs - BSc

Course Details

Available: Part- Time

Duration: 3 Semesters

Award: Undergraduate

Qualification: NFQ Level 8

Faculty: Science and Engineering

Course Type: Professional/Flexible

Fees: For Information on Fees, see section below.


Michelle Reinecke-Quain

Brief Description

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.

For Whom

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.


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

Start Date:  5th September 2020
End Date: August 2021

Semester 1- 5 x Saturdays classroom (due to Covid-19 restrictions Semester 1 will be online)

Semester 2- 6 Saturdays classroom (TBC)
Semesters 3 -2 Saturdays classroom (TBC)

Programme content

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 (6 ECTs)
Semester 3 Summer
Validation Principles & Practices (6 ECTs)
Project (12 ECTs)
Option: Career Development Programme


Entry Requirements

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 must 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 whose first language is not English are required to meet the University of Limerick English Language requirements. For more information please visit the International Education Division webpage here.

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