Course Overview

The Level 8 Higher Diploma in Medical Technologies Regulatory Affairs and Quality provides students with an introduction to the core elements of the product development lifecycle and the associated role of a Medical Technology Regulatory Affairs and/or Quality professional.  The programme ensures that students acquire a good, fundamental understanding of all applicable regulations and skills to address the ever-changing environment of Medical Technologies Regulatory Affairs and Quality.

The Higher Diploma in Medical Technology Regulatory Affairs and Quality programme has been specifically designed to meet the growing requirements of medical technology companies in filling regulatory and quality assurance roles. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed jointly by NUI Galway and IT Sligo, in conjunction with external professionals and industry practitioners who have all the required expertise, knowledge, skills and experience to deliver the education and training required to the highest international standards.

The course will link the existing regulations to regulatory requirements and how those requirements are executed across the medical device lifecycle, for example; how to develop technical documentation for regulatory submissions (regulatory affairs professionals), how to perform vigilance post market surveillance requirements (Vigilance specialist), core quality management standards and requirements (QA or Compliance Specialist) and testing requirements to demonstrate safety and efficacy of a medical device (R&D Engineer). 

Regulatory Affairs and Quality personnel within the medical technology products sector are responsible for assuring that pertinent government obligations, market-driven demands, and evolving scientific conventions are understood and addressed by various stakeholders of the medical and healthcare system.  Given the evolving nature of international regulations regulatory affairs and quality assurance professionals must continually grow their knowledge and skills to be effective and to advance in their careers. This course will ensure the development and enhancement of those skills.  

 The programme aims are to: 

  • Provide participants with a fundamental grounding in medical device regulatory and quality requirements.
  •  Provide necessary training to convert personnel with life sciences qualifications to transition into specialist roles in medical technology quality assurance and/or regulatory affairs functions and upskill medical technology professionals in the regulatory framework in their existing roles. 
  •  To ensure that participants have sufficient skills and knowledge to employ a fundamental level of data analysing, sythesising, summarising and writing skills in a regulatory environment
  •  Foster participants’ intellectual development and develop skills to work and communicate effectively through various media
  •  To ensure participants have the skills and ability to function within, and adapt to, a changing technical work environment and evolving regulatory frameworks
  •  To ensure the participants can provide appropriate input and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to people around the world.

The course will enable Regulatory Affairs and Quality Assurance personnel in the Medical Technology industry to understand all current device and diagnostic regulations and to develop the skills necessary to address and prepare for the ever-changing global environment of Regulatory Affairs and Quality Assurance. Upon successful completion of the programme, participants receive an NFQ Level 8 award of 30 credits. Upon successful completion of the programme, participants receive an NFQ Level 8 Higher Diploma award of 60 credits.

Applications and Selections

Graduates who have a level 7 qualification in a relevant area of Science, Engineering or Technology are eligible to apply for this programme.  Applications from candidates who hold a Level 7 primary degree in a non-technical subject, and who have at least five years medical technology industry experience in quality and /or regulatory affairs will be considered. Candidate interviews may be used to assess candidates’ suitability for the programme. 

International students, whose first language is not English, will be required to prove their English competency through their school leaving examination or matriculation examination or by achieving the minimum standard in a recognised English language test e.g. IELTS English language proficiency of 6.5 (with no band less than 6.0 in each element of the test) or equivalent. 

International students, whose first language is not English, will also need to provide evidence of their oral communication skills at interview. In addition to demonstrating their English language competency, they will need to provide evidence of having relevant experience in research (laboratory and/or computational desk based research) at undergraduate level or post-graduation.

Who Teaches this Course

The programme will be delivered by academic staff from NUI Galway and IT Sligo, with expertise in Regulatory Affairs and Quality, with guest lectures and workshops involving Regulatory Affairs experts and practitioners from the Medical technology industry sector.

The staff associated with the programme development and delivery include:

  • Prof. Terry Smith (NUI Galway)—Co-Director
  • Ms Mary Butler (IT Sligo)—Co-Director
  • Ms Deidre Barrow (Med Tech Regulatory Affairs Consultant)—Lecturer
  • Dr Olivia McDermott (NUI Galway)— Lecturer
  • Dr Sandra Ganly (NUI Galway)—Lecturer
  • Dr Stephen Daly (IT Sligo)—Lecturer
  • Dr Ailish Breen (IT Sligo)—Lecturer
  • Dr Mary Garvey (IT Sligo)—Lecturer
  • Dr Yvonne Lang  (IT Sligo) – Lecturer
  • Dr Tom  Patton (IT Sligo)
  • Dr Colin Fowley (IT Sligo)

Requirements and Assessment

Key Facts

Entry Requirements

Graduates who have a level 7 qualification in a relevant area of Science, Engineering or Technology are eligible to apply for this programme.  Applications from candidates who hold a Level 7 primary degree in a non-technical subject, and who have at least five years medical technology industry experience in quality and /or regulatory affairs will be considered. Candidate interviews may be used to assess candidates’ suitability for the programme. 

International students, whose first language is not English, will be required to prove their English competency through their school leaving examination or matriculation examination or by achieving the minimum standard in a recognised English language test e.g. IELTS English language proficiency of 6.5 (with no band less than 6.0 in each element of the test) or equivalent. 

International students, whose first language is not English, will also need to provide evidence of their oral communication skills at interview. In addition to demonstrating their English language competency, they will need to provide evidence of having relevant experience in research (laboratory and/or computational desk based research) at undergraduate level or post-graduation.


Additional Requirements

Duration

2 years, part-time

Next start date

September 2018

A Level Grades ()

Average intake

30

Closing Date

17 August 2018

Next start date

September 2018

NFQ level

Level 8

Mode of study

PART-TIME—online distance learning

ECTS weighting

60

Award

CAO

PAC code

GYS21

Course Outline

The Level 8 Higher Diploma in Medical Technology Regulatory Affairs and Quality is a two year part-time programme (60 credits). The programme is made available online using a combination of distance-learning / e-learning technologies, with some optional workshops. The educational elements are provided by NUI Galway and Institute of Technology Sligo staff. Additional lecturing, as required, may be provided by industry specialists and practitioners.

The programme consists of 12 modules, each worth 5 ECTS. The programme is delivered over four semesters (two academic years). Three modules are delivered per semester.

Assessment of students will be through continuous assessment of each module, which will include written assignments, workshop-based problem solving, and open-book exams using multiple choices, matching questions as well as short and long answer questions. 

Year 1 

Semester 1 Modules (each module is 5 ECTS)

  1. Introduction to Quality Management Systems
  2. Fundamentals of EU Medical Device Regulations
  3. Auditing and Compliance 

Semester 2 Modules (each module is 5 ECTS)

  1. Fundamentals of US Medical Device Regulations
  2. Risk Assessment
  3. Validation and Calibration 

Year 2 

Semester 3 Modules (each module is 5 ECTS)

  1. Fundamentals of Global Medical Device Regulations
  2. Sterilisation & Biocompatability
  3. Operations Management. and GMP 

Semester 4 Modules (each module is 5 ECTS)

  1. Fundamentals of Medical Device Clinical Trials
  2. Introduction to Market Vigilance & Labelling
  3. Technical Report Writing
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Further Education

Following completion of the Higher Diploma (60 credits) students are eligible to apply to undertake the MSc in Medical Technologies Regulatory Affairs, a part-time distance learning Level 9 programme jointly delivered by NUI Galway and IT Sligo.

Why Choose This Course?

Career Opportunities

This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs or Quality environment within the highly successful and growing Irish Medical Technology industry sector, with over 30,000 people currently employed.

It has been specifically designed to meet the growing requirements of medical technology companies in filling regulatory and quality assurance roles. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed in conjunction with a taskforce comprised of regulatory experts from industry, industry practitioners and representatives from the regional skills for a west and north west.   

The Irish Medtech Association (IMA) Skillnet asked senior MedTech industry executives to identify the current number of employees required to meet current skills demand, as well as forecasted number of employees required in MedTech organisations up to 2020. The IMA report (2017) has estimated that 4,000 additional Medical Technologies jobs will be added by 2020, with a 43% increase in staff numbers in the regulatory affairs functions and 17% in Quality roles.

Who’s Suited to This Course

Learning Outcomes

 

Work Placement

Study Abroad

Related Student Organisations

Course Fees

Fees: EU

Fees: Tuition

Fees: Student levy

Fees: Non EU

Find out More

Terry_and_Mary

Course Co-Director:

Prof. Terry Smith
T: +353 91 492 022
E: terry.smith@nuigalway.ie

Course Co-Director:
Ms Mary Butler
E: butler.mary@itsligo.ie


Lecturer and Quality and Regulatory Affairs Expert: 
Dr Olivia McDermott
E: Olivia.mcdermott@nuigalway.ie


Lecturer and Medical Technology Regulatory Affairs consultant:
Deirdre Barrow
E: Barrow.Deirdre@itsligo.ie   

 

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