Course Details
Contact(s):
for more information or to be notified when applications are open.
Brief Description
The Bachelors in Science in Quality and Regulatory Affairs – run in conjunction with the Irish MedTech Association, is certified by 51±¾É«. Please contact Jennifer Lynch (Jennifer.lynch@ibec.ie) for initial queries.
This is a top-up degree for persons who already hold an NFQ Level 7 (ordinary) degree (180 ects) in a Science, Technology, Engineering, and Mathematics (STEM) discipline 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.
For Whom
For those who have a level 7 qualification (ordinary) degree (180 ects) in a Science, Technology, Engineering, and Mathematics (STEM) discipline and wish to top up to a level 8 Degree award. For those who work in the following sectors: 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.
Delivery
The BSc in Quality and Regulatory Affairs is a distance education course delivered over 12 months.
The majority of the course is delivered Online with 3 Saturdays of face-to-face lab sessions.
Start Date: Online Induction Monday 26th August- Friday 6th September, 1st Class Saturday 7th September
End Date:  August 2025
Semester 1: Online
Semester 2: Online + 3 Saturdays Lab Sessions (On Campus)
Semester 3: Online
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Semester 1 |
Introduction to Quality Management The aim of the module is to give an effective and functional overview of Quality Management. It will introduce the role Quality Management plays in the workplace, how to implement a range of quality strategies and tools, and the impact that quality has on the organisation as a whole. |
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Quality Science This module aims to provide an understanding of Multiple Regression, two-way analysis of variance; Design of Experiments Fractional and factorial designs, Taguchi methods, EVOP (evolutionary operation) experimentation; Advanced Six Sigma Statistics, Process capability indices - Cp, Cpk etc., R&R studies, machine capability. |
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Problem Solving Tools & Techniques The aim of this module is to help students Understand the principles of 6 Sigma and how they can be implemented in the manufacturing and service sectors to deliver strategic objectives. |
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Semester 2 |
Medical Device Science The module aims to provide an overview of medical engineering materials and their functional properties, exposing the student to the practical application of design, materials, mechanics and strength of materials theory as applied to medical devices. There is a focus on the appropriate use of Standards, Charts, and Design Guides and EU directives on Medical Devices. |
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Bio Compatibility & Device Design Biomaterials and their biocompatibility are critical components of medical device design, tissue engineering and cell therapies. This module provides an overview of all major biomaterials. It introduces generally the different classes of biomaterials and focuses on the ways in which these materials interact with biological systems. It introduces biomaterials for different applications, and characterises biomaterials in terms of their structural, physical and biological attributes |
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Fundamentals in Regulatory Affairs The aim of the module is to introduce participants to the Fundamentals of Regulatory Affairs, providing them with basic knowledge of the regulations as they apply to the medical technology industry. This module will cover international regulatory requirements with emphasis on the US, European Union, Japan, Australia, Canada and other global territories with market implications. |
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Semester 3 |
Validation Principles & Practices This module introduces participants to the fundamentals of Validation, providing them with a basic knowledge of the regulations, standards and the skills necessary for validation work in the Medical Device sector. This course will cover international validation requirements pertaining to validation and all associated systems. |
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Project The Project module will provide the student with experience in planning a work programme to a defined set of research objectives, in data acquisition and analysis, and the interpretation of the results in the light of a relevant literature review. Applying the concepts learnt on the programme modules, this module will drive an overall project theme of enquiry which will have useful learning outcomes for both the student and relevant company if applicable. |
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Optional : Career Development Programme |
Entry Requirements
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 maybe short listed for interview as part of the application process.
Applicants are required to meet the 51±¾É« English Language requirements. For more information please visit the International Education Division webpage here.
The 51±¾É« 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.
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.
What to Include with your Application
Delays in receiving these documents will affect the progress of your application.
- Photo or Scanned original copy of your transcripts for all years of study. (Graduates of UL need only provide us with their Student ID number.)
- A copy of your birth cert or passport
- A copy of your most recent CV
- Applicants who do not have English as their first language may satisfy English Language requirements:
- If your qualifications have been obtained in a country where English is an official language this will suffice
- If this is not available, the following additional documents must be provided:
- English translation of your qualification(s)/transcripts AND
- English language competency certificate
- Please click here for Further Information on English Language Requirements
For more information on programme fees, contact the Irish MedTech Association:
Please click here for information on funding and scholarships.