Course Overview

The Level 8 Certificate 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.

 This programme has been designed to meet the growing requirements of Irish 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 selected 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 enable Regulatory Affairs and quality 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. Upon successful completion of the programme, participants receive an NFQ Level 8 award of 30 credits.

 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. 
  • Foster participants’ intellectual development and develop skills to work and communicate effectively through various media.

                                                                      

Applications and Selections

Applications are made online via The Postgraduate Applications Centre (PAC). 

In order to apply for this programme please complete all of the steps below:

Step One:  Ensure you are eligible—entry criteria

  • Students with a Level 7 or higher qualification in Science or Engineering are eligible for the proposed Level 8 programme.
  • Students with a Level 7 or higher qualification in a non-technical subject area but who hold a minimum of 5 years relevant medtech industrial experience in regulatory affairs or quality are eligible for the Level 8 programme.

Step Two:  Have all of the supporting documentation in place

Visit our Supporting Documents website for document requirements for this course.

Step Three: Ensure that you meet the English Language requirements

All applicants, whose first language is not English must present one of the following qualifications in the English language and have no less than 6.5 in ANY component. NOTE: Language tests must be undertaken no more than two years prior to commencement of your programme at the University.

IELTS

TOEFL

Pearson PTE

6.5

88

61

6.5

88

61

6.5

88

61

 The NUI Galway TOEFL institution code is 8861.

Any PAC application queries should be emailed to postgradadmissions@nuigalway.ie 

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

Requirements and Assessment

Key Facts

Entry Requirements

  • Students with a Level 7 or higher qualification in Science or Engineering are eligible for the proposed Level 8 programme.
  • Students with a Level 7 or higher qualification in a non-technical subject area but who hold a minimum of 5 years relevant medtech industrial experience in regulatory affairs or quality are eligible for the Level 8 programme.

Additional Requirements

Duration

1 year part-time

Next start date

September 2017

A Level Grades ()

Average intake

30

Closing Date

Please refer to the review/closing date website.

Next start date

September 2017

NFQ level

8

Mode of study

Taught

ECTS weighting

30

Award

CAO

PAC code

GYS28

Course Outline

  • The programme is offered as a one year part-time Level 8 Certificate in Medical Technology Regulatory Affairs and Quality (30 credits)
  • The Certificate programme is also available for students to undertake in a modular format, enabling students to select any individual module or combination of modules in any year, up to a maximum of 3 modules per semester
  •  The module programme offering gives students the option to complete all 6 taught modules five  six years to obtain a Level 8 Certificate

The programme is being made available online using a combination of distance-learning/e-learning technologies and some face-to- face workshops for an overall blended learning approach. The educational elements is provided by the Institute of Technology, Sligo, and NUI Galway staff. Additional lecturing, as required, may be provided by industry specialists and practitioners.

 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

Further Education

Following completion of the one year Level 8 Certificate in Medical Technology Regulatory Affairs and Quality (30 credits) students are eligible to continue for a second Year to complete a Level 8 Higher Diploma in Medical Technology Regulatory Affairs and Quality (60 credits). The Higher Diploma award ewill be available from September 2018.

Graduates with the Higher Diploma award will be 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 invited 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

€4,500 p.a 2017/18

Fees: Tuition

Fees: Student levy

Fees: Non EU

€8,000 p.a. 2017/18
For further information on postgraduate funding & scholarship opportunities please see here.

Find out More

Course Co-Director:
Prof. Terry Smith
T: +353 91 492 022
Eterry.smith@nuigalway.ie

FUEL Project Partners

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