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 STEM 3 year 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 online and onsite full classroom days over the 12 months.
Participants attend face-to-face sessions which includes 9 Saturdays, during the year 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 Development 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 Development 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 to the Irish Medtech Springboard. 10% Cost is €690.00
Mode of Delivery – Blended
There will be 9 Saturdays of face-to-face classroom based learning; plus online learning throughout the years programme. These are recorded where possible, however the three laboratory days cannot be recorded and classroom attendance is highly recommended for these three days.
Start Date: 3 September 2022 (TBC) (induction 22 Aug – 2 Sep)
End Date: August 2023
Semester 1: (3 Sept 2022 – 10 Dec 2022) – 5 Saturdays (Online) plus online lectures.
Exam will be in December. (Times and details will be confirmed near to the date)
Semester 2: (Jan 2023 – April 2023) – 3 Saturdays = 3 Classroom in person Laboratory Days plus online lectures.
Semester 3: (May 2023 – Aug 2023) – 0 Saturdays. Online Lectures will be Thursday evenings.
Semester 1 Starts 3 September 2022. (tbc)
3 Sept 2022 is the first day of the programme. Orientation/Induction starts 22 Aug; to be completed before the start date.
Semester one – full day workshops are online.
SAT 1 – 03 Sep-22 9:00 – 17:00
SAT 2 – 24 Sep-22 9:00 – 17:00
SAT 3 – 15 Oct-22 9:00 – 17:00
SAT 4 – 05 Nov-22 9:00 – 17:00
SAT 5 – 26 Nov-22 9:00 – 17:00
Exam will be in December. (Times and details will be confirmed nearer to the date)
(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 2022
- Introduction to Quality Management (6 ects.)
- Quality Science (6 ects.)
- Problem Solving Tools & Techniques (6 ects.)
Semester 2 Spring 2023 (includes three laboratory days: Sat 1 tbc & Sat 2 tbc & Sat 3 tbc)
- Medical Device Science (6 ects.)
- Bio Compatibility & Device Design (6 ects.)
- Fundamentals in Regulatory Affairs (9 ects.)
Semester 3 Summer 2023
- Validation Principles & Practices (9 ects.)
- Project (12 ects.)
- Option: Career Development Programme
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.
Places are given to those most eligible for 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 be attached to your application; (Application cannot be processed without these documents attached, once all documents are received online, with your application, status will be updated to pending. Places will be given to those who meet the eligibility criteria and are most eligible for the course.)
1. If you are employed – a letter from your employer / most recent payslip – MUST BE DATED within 6 weeks of the start date of the course.
1. If you are a homemaker you need to have a letter confirming this, signed by commissioner of oath. – MUST BE DATED within 6 weeks of the start date of the course
1. If you are unemployed you need to send a copy of your jobseeker benefit/allowance slip, or letter from social welfare office. – MUST BE DATED within 6 weeks of the start date of the course
2. Copy of transcripts to support your academic history – Proof of L7 degree – 180 credits (3 year STEM degree)
4. Proof of Address – dates must show 3 years residence prior to start of course. Proof for each year 2020, 2021, 2022., or 2021, 2022, 2023, etc.
5. Proof of identification – Passport/Drivers Licence
6. Visa Requirements/Stamp 4 etc
7. Proof of PPS number
Irish Medtech Springboard will contact you closer to start date of course (within 4-5 weeks of start to collect this data prior to enrolment of course)
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.