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 session 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 (CA4003 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 (CA4003 CAREER DEVELOPMENT 6 ECTS)
Semester 1 Autumn 2018
- Introduction to Quality Management (6 ects.)
- Quality Science (6 ects.)
- Problem Solving Tools & Techniques (6 ects.)
Staurdays in University of Limerick: 8th September, 29th September, 27th October and 24th November 2018
Semester 2 Spring 2019
- Medical Device Science (6 ects.)
- Bio Compatibility & Device Design (6 ects.)
- Fundamentals in Regulatory Affairs (9 ects.)
Semester 3 Summer 2019
- 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.
Start Date: 08/09/2018
End Date: 31/08/2019
Semester 1 4 x Saturdays classroom
Semester 2 5 Saturdays classroom
Semesters 3 4 Saturdays classroom
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.