Bachelors in Science in Quality and Regulatory Affairs

Irish Medtech Association (0720)
Key Programme Details
Award

BSc in Quality and Regulatory Affairs

NFQ Level

8 About NFQ

Delivery Method

Mixed

Mode

Part-Time

ECTS Credits

60

Department

School of Engineering and of Chemical Sciences

Skills Area

Advanced Manufacturing

General Information
Contact

Michelle Reinecke Quain

Email

michelle.reinecke-quain@ibec.ie

Phone

061431802

Address

Irish Medtech Association Springboard
Ibec
Gardner House
Charlotte Quay
Limerick

Role

Network Executive

Important Dates
Application Deadline

31/08/2017

Start Date

09/09/2017

About this Course

The Bachelor of 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. 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 12 Saturday, face-to-face sessions, and engage in distance education and online learning throughout the one year 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)

Objectives

Breakdown of MODULES:

- Introduction to Quality Management - CQE
- Quality Science - CQE
- Problem Solving Tools & techniques - CQE
- Medical Device Science
- Biocompatability & Device Design
- Fundamentals in Regulatory Affairs
- Validation Principles & Practices
- Project

Entry Requirements

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.

1. Applicants should have a NFQ Level 7 (ordinary) degree (180 ects) in a Science, Technology, Engineering, and Mathematics (STEM) discipline.

2. Applicants should have 3 years work experience in a regulated sector.

3. 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.

4. 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.

Long Description

The Bachelor of 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. 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 12 Saturday, face-to-face sessions, and engage in distance education and online learning throughout the one year 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)

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. It 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

Autumn 2017 Semester 1 3 Saturdays and online lectures
Jan 2018 Semester 2 5 Saturdays and online lectures
June 2018 Semester 3 4 Saturdays and online lectures

Delivery Location

Autumn 2017 Semester 1 3 Saturdays and online lectures TBA
Jan 2018 Semester 2 5 Saturdays and online lectures TBA
June 2018 Semester 3 4 Saturdays and online lectures TBA

Delivery Notes

Blended - face to face and online

Admissions Contact Details
Instructor

Michelle Reinecke Quain

Address

Irish Medical Devices Association Confederation House 84-86 Lower Baggot Street Dublin 2 Ireland

Phone

061431802

Email

michelle.reinecke-quain@ibec.ie

RPL Information

University of Limerick RPL Policy

Application Procedures

Applicants are expected to apply online through Irish Medtech Association Springboard Website or the Springboard + website.
Please upload a copy of your CV for review and approval by the college.