Bachelors in Science in Quality and Regulatory Affairs

The Bachelors in Science in Quality and Regulatory affairs – certified by University of Limerick 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.

Participants attend face-to-face sessions 4 to 5 Saturdays during each semester and engage in distance education and online learning throughout the programme. The combination of Saturdays on campus and online distance education supports Springboard+ participants in continuing to seek work and an option to complete the programme when they find employment.

Each learner will also have the opportunity to participate in the UL Careers Development programme (Career Developmet 6 ects) which prepares learners with CV and career coaching, develops a LinkedIn presence, and interview skills.

On successful completion of the training programme, the participants will receive a Bachelors in Science in Quality and Regulatory Affairs, Level 8 60 ects. and an optional Career Development Module (Career Developmet 6 ects)

Note: All employed participants of the Bachelors in Science in Quality and Regulatory Affairs will be required to pay 10% of the overall costs of the programme.  10% Cost is €690.00


Semester 1 Starts 5th Sept 2020.

5th Sept 2020 is the first day of the programme. Induction starts 24th Aug; to be completed before the start date.

With Covid-19 planning for the remainder of the year, the Autumn semester will be delivered online; so there will be no face-to-face classroom days in Semester 1.

Full day workshops online

(We would like to highlight the need for students to have headsets/mics/camera and good Internet access for the course; as the first semester will be completely online. A good internet connection will be essential for students to get the most out of the course and end of semester online assessments)

Semester 1 Autumn 2020

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

Semester 2 Spring 2021

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

Semester 3 Summer 2021

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

Mode of Delivery

There will be approx 13 Saturdays of face-to-face learning plus online learning throughout the years programme. (This will be reviewed, and delivered online and virtually, if necessary, due to Covid-19.)

Start Date: 5 September 2020 (induction 24th Aug – 4th Sep)
End Date: August 2021

Semester 1: (Sept ’20 – Dec ’20) – 5 Saturdays (tbc) and online lectures.
Exam will be in December. (Times and details will be confirmed near to the date)

Semester 2: (Jan ’21 – April ’21) – 5 Saturdays (tbc) and online lectures.

Semester 3: (May ’21 – Aug ’21) – 4 Saturdays (tbc) and online lectures.

Entry requirement for applicants

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.

Further detail on Entry requirements:

Regulated sectors include the 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.

The University of Limerick policy on the Recognition of Prior Learning will apply to applications for this programme.

Not all eligible candidates may be offered a place on the programme.

Applicants may be short listed for interview as part of the application process.


Note: All employed participants of the Bachelors in Science in Quality and Regulatory Affairs will be required to pay 10% of the overall costs of the programme.  10% Cost is €690.00

The following documents must also be attached to your application;

  1. If you are employed – a letter from your employer / P60 summary confirming you are employed.
  2. If you are a homemaker you need to have a letter confirming this, signed by commissioner of oath.
  3. If you are unemployed you need to send a copy of your job seeker benefit/allowance slip, or a letter from your social welfare office.
  4. Copy of transcripts to support your academic history.
  5. CV

Note: By applying to this course, through the Irish Medtech Springboard, you are agreeing to your data being shared with the relevant staff and trainers within the Irish Medtech Springboard, and the University of Limerick, to facilitate this level 8 award; Bachelors in Science in Quality and Regulatory Affairs.


Click here to apply online at