Bachelors in Science in Quality and Regulatory affairs (Bachelors in Science in Quality and Regulatory affairs)

Irish Medtech Association (B.Sc in Q & RA 2021)
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.reinecke-quain@ibec.ie

Phone

087 190 6802

Address

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

Important Dates
Application Deadline

11/08/2021

Start Date

04/09/2021

End Date

30/08/2022

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 13 Saturday, face-to-face 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 are online 09:00-17:00
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 13 online Saturday, face-to-face 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 are online 09:00-17:00
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

Why Choose This Course

The Bachelors in Science in Quality and Regulatory affairs 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.
This course is also suitable for unemployed persons that meet the entry requirements.

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

4 Sept 2021 is the first day of the programme. Orientation/Induction starts 23 Aug; to be completed before the start 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 2021 - Full day workshops will be ONLINE
04-Sep-21   9:00 - 17:00
25-Sep-21   9:00 - 17:00
16-Oct-21    9:00 - 17:00
30-Oct-21   9:00 - 17:00
20-Nov-21  9:00 - 17:00
Exam 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 2022 - Full day workshops online (Jan 2022 - April 2022) 5 Saturdays (tbc) and online lectures.

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

Semester 3 Summer 2022 (May 2022 - Aug 2022) - 4 Saturday workshops online, plus online lectures

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

There will be approx 13 Saturday workshops all online 09:00-17:00 (face-to-face learning) plus online learning throughout the years programme. 
Blended, with virtual & Live classrooms, live weekly tutorials, and weekly pre-recordings.

Delivery Location

Online
Limerick location if any classroom based lectures TBC

Delivery Notes

Blended

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.reinecke-quain@ibec.ie

Application Procedures

Please complete the Irish Medtech Springboard application.

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
1. If you are a homemaker you need to have a letter confirming this, signed by commissioner of oath.
1. If you are unemployed you need to send a copy of your jobseeker benefit/allowance slip, or letter from social welfare office.
2. Copy of transcripts to support your academic history - Proof of L7 - 180 credits - transcripts
3. CV

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;

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.