Medical Technologies Regulatory Affairs & Operations

Course Overview
The Level 8 Certificate in Medical Technologies Regulatory Affairs and Operations has been specifically designed to meet the growing requirements of medical technology companies in filling regulatory and quality assurance roles, introducing a focus on operations. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed jointly by University of Galway and IT Sligo, in conjunction with selected external professionals, including regulatory experts from industry, 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 links 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). 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 and quality. Upon successful completion of the Cert programme, participants receive an NFQ Level 8 award of 30 credits.

The course 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, introducing a focus on Operations. 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 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.

Programme objectives:
- To produce graduates with the essential breadth and kind of knowledge, skills set and competencies required to function in specialist roles in the medical technology regulatory affairs function, to upskill medical technology professionals in the regulatory framework in their existing roles and to be capable of contribution to regulatory projects and projects with a regulatory element in a medical device company environment.

- To ensure that participants have sufficient skills and knowledge to employ a fundamental level of data analysing, synthesising, summarising and writing skills in a regulatory environment.

- To ensure that participants can communicate and defend scientific data and findings in a variety of forms to regulatory agencies, medical care systems, internal personnel and the public.

- 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.

Course Overview
The Level 8 Certificate in Medical Technologies Regulatory Affairs and Operations has been specifically designed to meet the growing requirements of medical technology companies in filling regulatory and quality assurance roles, introducing a focus on operations. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed jointly by University of Galway and IT Sligo, in conjunction with selected external professionals, including regulatory experts from industry, 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 links 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). 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 and quality. Upon successful completion of the Cert programme, participants receive an NFQ Level 8 award of 30 credits.

The course 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, introducing a focus on Operations. 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 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.

Course Outline
The Level 8 Certificate in Medical Technology Regulatory Affairs and Operations programme is a one year part-time 30 ECTS course, delivered over two Semesters from September–May each year. The programme is made available online using distance-learning / e-learning technologies, with one optional workshop. The educational elements are provided by University of Galway and Institute of Technology Sligo staff. Additional lecturing, as required, may be provided by industry specialists and practitioners. The course consists of 6 modules, with 3 modules delivered per semester. Students undertaking the Certificate must complete all 6 taught modules, to obtain Level 8 Cert award. Assessment of students is through continuous assessment of each module, including written assignments, open-book exams using multiple choices, matching questions as well as short and long answer questions, and workshop-based problem-solving. Assessment of students is through continuous assessment of each module, including written assignments, e-tivities, problem solving, and online open-book exams using multiple choices, matching questions as well as short and long answer questions.

On successful completion of this programme graduates will:
- Have a general knowledge and understanding of the theory and best practice relating to medical device regulatory structures and procedures.

- Demonstrate a general knowledge and understanding of current medical device global regulations and the role of the regulatory affairs professional and quality assurance personnel in the industry.

- Be able to employ appropriate fundamental level of data analysing, synthesising, summarising and writing skills to evaluate aspects of regulatory affairs and quality/operations indicators within medical technology industry.

- Communicate and defend scientific and quality information/regulatory findings in a variety of forms to regulatory agencies, medical care systems, internal personnel and the public.

- Appreciate the complex and fluid relationships of medical technology processes, prescribed regulatory framework and selected support activities.

- Apply concepts and skills learnt in a variety of contexts.

- Work effectively in a medical technology environment by: acting autonomously and thinking independently to meet regulations, or by participating constructively in a team environment within a technical field, to ensure the team is operating within the appropriate regulations.

Semester 1 Modules (each module is 5 ECTS)
Fundamentals of Global Medical Device Regulations.
Sterilisation & Biocompatibility.
Operations Management and GMP.

Semester 2 Modules (each module is 5 ECTS)
Fundamentals of Medical Device Clinical Trials.
Introduction to Market Vigilance & Labelling.
Technical Report Writing.

- Graduates with a level 7 qualification or higher 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.

- Students applying on the basis of formal qualifications and supplementary accredited prior learning (APL) for core pre-requisites will be required to submit full details and references to the Programme Board for consideration of educational equivalencies. Prior experiential learning will be assessed using guidelines recommended by the Academic Council of IT Sligo and University of Galway.

- All applicants, whose first language is not English must present a qualification in the English language e.g. IELTS (no less than 6.5 in ANY component); TOEFL ((no less than 88 in ANY component); and Pearson (no less than 61 in ANY component). NOTE: Language tests must be undertaken no more than two years prior to commencement of your programme at the University.

IMPORTANT: To find out how to apply for the course please contact butler.mary@itsligo.ie or olivia.mcdermott@universityofgalway.ie.

How to apply
We encourage all applicants to apply as early as possible.

Review/Closing Dates (for Taught Programmes)
For most programmes, University of Galway does not set specific closing dates for receipt of applications. Applications will be accepted on a rolling basis and course quotas will be reviewed continuously throughout the application cycle with the exception of applications for some programmes which are reviewed after the specified closing date. Candidates who do not have their final degree marks available may be made a conditional (provisional) offer.

Online Application
Applications to most postgraduate programmes at University of Galway are made online via www.universityofgalway.ie/apply (see "Application Weblink").

1 year, part-time distance learning (100% online). Mode of study: Online Learning.

Next start date: September 2024.

Review/Closing Dates (for Taught Programmes)
For most programmes, University of Galway does not set specific closing dates for receipt of applications. Applications will be accepted on a rolling basis and course quotas will be reviewed continuously throughout the application cycle with the exception of applications for some programmes which are reviewed after the specifed closing date*. Candidates who do not have their final degree marks available may be made a conditional (provisional) offer.

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 further opportunities in Quality and Operations roles.

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).

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 University of Galway and IT Sligo.