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 two laboratory days cannot be recorded, and classroom attendance is mandatory for these two days.

Start Date: 7 September 2023 (induction 26 Aug – 6 Sep)

7 Sept 2023 is the first day of the programme. It is on UL campus.

Orientation/Induction starts 26 Aug; to be completed before the start date.

End Date: August 2025

Semester 1: (Sept 2024 – Dec 2024) – 5 Saturdays full day 9am-5pm ONLINE, plus weekly Monday night online 1 hr lectures 7pm – 8pm. Exams mid-December.

Semester 2: (Jan 2025 – April 2025 – 2 Saturdays = 2 Classroom in person Laboratory Days plus online lectures. Tutorials are Tues evenings.

Semester 3: (May 2025 – Aug 2025) – 0 Saturdays. Online Tutorials will be Thursday evenings.

 

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. 

 

Modules/Schedule

Semester 1 – Autumn 26/08/24 – 30/11/24 – Tutorials will be one hour ONLINE Monday Nights 7pm – 8pm

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

Full day workshops are full days ONLINE 9am – 5pm (First day on campus in UL)

SAT 1: – 07 Sep-24   10:00 – 17:00 = Basic Stats/Minitab (First day on campus in UL Room tbc)
SAT 2: – 28 Sep-24  10:00 – 17:00 = Probability
SAT 3: – 19 Oct-24   10:00 – 17:00  = Hypothesis
SAT 4: – 9 Nov-24    10:00 – 17:00 = ANOVA/Regression/DOE
SAT 5: – 30 Nov-24 10:00 – 17:00  = Reliability

Final day followed by a Study Week, followed by Exam week. The three exams are each one hour in duration, over 3 hr window.
Fri 13 Dec 19:00-22:00, Sat 14 Dec 10:00-13:00 & Sat 14 Dec 14:00-17:00

SEMESTER ONE:
Basic Statistics with Minitab Saturday 07 Sept 10:00-16:30 (onsite in UL)
Basic Statistics with Minitab Monday 9 Sept 19:00-20:00 (Online)
Management & Leadership Monday 16 Sept 19:00-20:00 (Online)
The Quality System Saturday 28 Sept 10:00-17:00 (Online)
Probability Theory & Distributions Monday 30 Sept 19:00-20:00 (Online)
Product Process & Service Design Monday 7 Oct 19:00-20:00 (Online)
Statistical Decision Making Saturday 19 Oct 10:00-17:00 (Online)
Product & Process Control Monday 21 Oct 19:00-20:00 (Online)
Statistical Process Control Monday 28 Oct @ 19:00-20:00 (Online)
Continuous Improvement, Process Capability & Risk Management Saturday 9 Nov 10:00-17:00 (Online)
Relationship between Variables & Design of Experiments Monday 11 Nov 19:00-20:00 (Online)
Reliability & Maintainability Monday 18 Nov 19:00-20:00 (Online)
Reliability & Maintainability Saturday 30 Nov Online 10:00-17:00 (Online)

Please note that the 1st Day of the course will be held on site in UL Room TBC: 10AM – 4.30PM to facilitate collection of course material and meet and greet with Tutors & Students.
All other Autumn classes will be held online.
Weekly tutorials = 7:00pm to 8:00pm & are recorded in Brightspace.
Classroom Days = 10:00am to 5:00pm, lunch 1:00pm to 2:00pm and 10 minute coffee breaks every hour.

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Semester 2 – 22/01/25 – 10/05/25 – Tutorials will be one hour ONLINE Tuesday Nights 7pm – 8pm

Schedule will be confirmed by UL in due course.

includes two laboratory days: (Sat 3 Feb 10:00-16:00  &   Sat 2 Mar 10:00-16:00)

  • Medical Device Science (6 ects.)  Three exams – will each be 1 hour in duration over a 12-hour window.
  • Bio Compatibility & Device Design (6 ects.) One exam – will be over a 3-day window dates tbc in due course
  • Fundamentals in Regulatory Affairs (9 ects.) No end of semester exams

Semester 3 – Summer  May 25 – August 25 – Tutorials will be one hour ONLINE Thursday Nights 7pm – 8pm

  • Validation Principles & Practices for Medical Device Industry (9 ects.) No end of semester exams
  • 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 stem major award of an honours degree are not eligible to apply for this programme.

Eligibility Requirement is a 3 year degree, Level 7 (ordinary) degree (180 ects) in a Science, Technology, Engineering, and Mathematics (STEM) discipline, plus 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 will be given to those who meet the eligibility criteria and are most eligible for the course.

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

 

 

If you are successful in your application, Once you accept your place on the course online through springboardcourses.ie website; The following documents must then be attached/re-uploaded to your application; (You will not be enrolled for funding unless all relevant data has been received (attached online). Once all documents are received online, with your application, status will be updated to enrolled.

Documents must be in date within six (6) weeks of commencement date of course (not the application date)

1. If you are employed – a letter from your employer / most recent payslip (please redact sensitive data) – MUST BE DATED within six (6) weeks of the start date of the course. An employers letter can include points 1, 4 & 5.
1. If you are a homemaker you need to have a letter confirming this, signed by commissioner of oath. – MUST BE DATED within six (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 two (2) 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)
3. CV
4. Proof of Residency – 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 Address
6. Proof of identification – Passport/Drivers Licence
7. Visa Requirements/Stamp 4 etc
8. 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 Ibec, and the University of Limerick, to facilitate this level 8 award; Bachelors in Science in Quality and Regulatory Affairs.

Apply

Click here to apply online at springboardcourses.ie