Bachelors in Science in Quality & Regulatory Affairs (Bachelors in Science in Quality & Regulatory Affairs)

Irish Medtech Association (B.Sc in Q & RA 2022)
Key Programme Details
Award

Bachelors of Science in Quality and regulatory Affairs

NFQ Level

Level 8 About NFQ

Delivery Method

Online, Classroom, Blended

Mode

Part Time

ECTS Credits

60

General Information
Contact

Michelle Quain

Email

michelle.quain@ibec.ie

Phone

087 190 6802

Address

Irish Medtech Springboard Ibec Midwest Gardner House Bank Place Charlotte Quay Limerick

Important Dates
Application Deadline

25/07/2022

Start Date

03/09/2022

End Date

31/08/2023

About this Course

The Bachelor of Science in Quality and Regulatory affairs - Certified by the 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. Participants attend a total of 9 Saturdays, face-to-face online and onsite sessions, and engage in distance education and online learning throughout the one year programme. The combination of Classroom Saturdays, and online distance education, supports Springboard+ participants in continuing to seek work and an option to complete the programme when they find employment.
Classroom days 09:00-17:00 / Workshops 09:00 - 17:00 are recorded where possible, however the THREE laboratory days ARE NOT RECORDED and it is highly recommended that you attend the three laboratory days on campus.
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).

Note: All participants of the BSc in Quality & Regulatory Affairs will be required to pay 10% of the overall costs of the programme. 10% Cost is 690.00

Entry Requirements

Applicants should hold an NFQ Level 7 (ordinary) degree (180 ects) in a Science, Technology, Engineering or 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 as well as their motivation and overall potential to be successful on the programme will be considered in evaluating the 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 other software and electronics industry.
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. This programme is a level 8 top-up degree programme.

Applicants already holding a Level 8 major award of an honours degree are not eligible to apply for this programme.

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;

Long Description

The Bachelor of Science in Quality and Regulatory affairs - Certified by the 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. Participants attend a total of 9 Saturday2, face-to-face online and onsite sessions, and engage in distance education and online learning throughout the one year programme. The combination of Classroom Saturdays, and online distance education, supports Springboard+ participants in continuing to seek work and an option to complete the programme when they find employment.
Classroom days 09:00-17:00 / Workshops 09:00 - 17:00 are recorded where possible, however the three laboratory days ARE NOT RECORDED and it is highly recommended that you attend the three laboratory days on campus.
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) .

Note: All participants of the BSc in Quality & Regulatory Affairs will be required to pay 10% of the overall costs of the programme. 10% Cost is 690.00

Mode of Delivery:
Approximately 9 Saturdays -
5 online (face-to-face learning) workshops & 3 classroom based in person laboratory workshops.
Plus Module 1 exam
09:00-17:00
Plus online learning throughout the years programme. 
Blended, with virtual & Live classrooms, live weekly tutorials, and weekly pre-recordings.

Career Opportunities

Quality Technician,
Quality Engineer
Quality Scientist
Regulatory Affairs Specialist
Regulatory Affairs Scientist
Validation Engineer
Validation Specialist
R&D Scientist
R&D Engineer
Maintenance Engineer
Manufacturing Engineer

Timetable Info

3 Sept 2022 is the first day of the programme. Orientation / Induction starts 22 Aug - Fri 2 Sept. (12 Days)
Online induction to be completed before the start date!

INDUCTION:
Components of induction:
Moodle navigation & tools Induction.
Hardware & Software requirements.
Digital Socialisation.
Programme Philosophy.

(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 - Full day workshops will be 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
PLUS Exam which will be in December. (Times and details will be confirmed nearer to the date)
Introduction to Quality Management (6 ects.)
Quality Science (6 ects.)
Problem Solving Tools & Techniques (6 ects.)

Semester 2 Spring 2023 - Full day workshops online (Jan 2023 - April 2023) 3 classroom based laboratory in person workshops, and online lectures.
Medical Device Science (6 ects.)
Bio Compatibility & Device Design (6 ects.)
Fundamentals in Regulatory Affairs (9 ects.)

Semester 3 Summer 2023 (May 2023 - Aug 2023) - 0 Saturday workshops. Classroom lectures are online on Thursday evenings.
Validation Principles & Practices (9 ects.)
Project (12 ects.)
Option: Career Development Programme


Mode of Delivery:
Approximately 9 Saturdays -
5 online (face-to-face learning) workshops & 3 classroom based in person laboratory workshops.
Plus Module 1 exam
09:00-17:00
Plus online learning throughout the years programme. 
Blended, with virtual & Live classrooms, live weekly tutorials, and weekly pre-recordings.

Delivery Location

Online + 3 face to face in person classroom days in Limerick (Venue tbc)

Induction - online - to be completed before the start date! Orientation/Induction starts 22 Aug - Fri 2 Sept. (12 Days)

INDUCTION:
Components of induction:
Moodle navigation & tools Induction.
Hardware & Software requirements.
Digital Socialisation.
Programme Philosophy.

Delivery Notes

Blended

Start Date: 3 September 2022 (induction 22 Aug – 2 Sep)
Induction - online - to be completed before the start date! Orientation/Induction starts 22 Aug - Fri 2 Sept. (12 Days)

INDUCTION:
Components of induction:
Moodle navigation & tools Induction.
Hardware & Software requirements.
Digital Socialisation.
Programme Philosophy.

End Date: August 2023

Admissions Contact Details
Contact Person

Michelle Quain

Address

Irish Medtech Springboard Ibec Midwest Gardner House Bank Place Charlotte Quay Limerick

Phone

087 190 6802

Email

michelle.quain@ibec.ie

Application Procedures

PLEASE NOTE IT IS THE RESPONSIBILTY OF THE APPLICANT TO READ THE APPLICATION PROCEDURES CAREFULLY, PARTICULARY ON SUPPORTING DOCUMENTATION. YOUR APPLICATION FOR FUNDING CANNOT BE PROCESSED UNTIL ALL DOCUMENTATION IS SUBMITTED.

The following documents must be attached to your application; (Application cannot be processed without these documents attached)
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 STEM L7 degree - 180 credits - transcripts
3. CV
4. Proof of Address - dates must show 3 years residence prior to start of course.
5. Proof of identification - Passport/Drivers Licence

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;

Once you have applied online through the Irish Medtech Springboard for the funding, your details will be sent to the University of Limerick BSC in Science course co-ordinator.
You will then have to complete the UL application,
UL confirm if you eligible for the programme
If you are offered a place and accept this place, the 10% fee needs to be paid to the Irish Medtech Springboard.
Once the fee has been paid and received, your place will be confirmed.
Invoice will be sent by Irish Medtech Springboard ( invoice incl the bank acc details)

During the year of this course the HEA will request two RE-REGISTRATIONS to confirm that you are still completing the course. Irish Medtech Springboard will send the details to you via email prior to each re-registration. This is mandatory.