Certificate in Medical Technology Regulatory Affairs and Operations (Online)

  • NFQ Level 8
  • Credits 30*
  • Course Code SG_SMEDO_E08
  • Award Certificate
  • Duration 1 year

Course Summary

This programme (SG_SMEDO_E08) has been designed to meet the growing requirements of Irish 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 NUI Galway and ATU 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, current and future knowledge of strategic operations including Industry 4.0, MedTech 4.0, and Smart Operations engineering and management in the context of a  GMP environment. Upon successful completion of the programme, participants receive an NFQ Level 8 award of 30 credits.

Programme Aims are:

  • Provide participants with a fundamental grounding in medical device regulatory structures and requirements.
  • Provide the training necessary to convert personnel employed in the Medical Technologies sector with life sciences qualifications (Level 6, Level 7, or Level 8) to transition into specialist roles in the medical technology quality assurance and/or regulatory affairs functions and to upskill medical technology professionals in the regulatory framework in their existing roles.
  • Foster the participant’s intellectual development in academic and industrial environments.
  • Develop participant's skills to work and communicate with appropriate autonomy and effectively through various media.

The programme objectives are:

  • 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, sythesising, 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 outline

The programme consists of a one year part-time Level 8 Certificate in Medical Technology Regulatory Affairs and Operations (30 credits). The programme shall be 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 will be provided by the Atlantic Technological Univerisity, and NUI Galway staff. Additional lecturing, as required, may be provided by outside specialists and practitioners.

The programme consists of 6 modules, each worth 5 ECTS. The programme is delivered over two semesters (one academic year). 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.

Who teaches this course?

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

Is there Funding available?

If an applicant is Employer funded and their Employer is a Member of the Next Level Skillnet, companies can avail of reduced Fees. Fees will be €1,350 per Semester – a discount of €900 per Semester. Total Fees reduced by €1,800 from €4,500 to €2,700.*

If an applicant is Employer funded but their Employer is not a Member of the Next Level Skillnet, companies can still avail of reduced Fees. Fees will be €2,025 per Semester – a discount of €225 per Semester. Total Fees reduced by €450 from €4,500 to €4,050*

* Subject to confirmation of funding support for each semester. See next level skillnet qualifying criteria at http://nextlevel.ie/at-a-glance/employee/

Key Course Information


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 NUI Galway and ATU 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.

Application Closing Date : 31st August 2022

Entry Requirements

Progression

Students who successfully complete the Level 8 Certificate in MedTech Regulatory Affairs and Operations may progress onto a follow on Year 2 programme to obtain a Level 8 Higher Diploma award (this can also be done by completing the other Level 8 Certificate in MedTech Regulatory Affairs and Quality).

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 two 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 ATU Sligo and NUI Galway.

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.

The Level 8 Higher Diploma, Certificate in Medical Technology Regulatory Affairs and Operations and also the Certificate 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 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 Medical Devices Association (IMDA) states “The medical technology sector in Ireland is recognised as one of the five global emerging hubs. The sector employs over 29,000 people in Ireland and is the second largest employer of medtech professionals in Europe. Ireland is one of the largest exported of medical products in Europe with annual exports of €12.6 billion and companies here directly export to over 100 countries worldwide. As many as 18 of the world’s top 25 medical technology companies have a base in Ireland and 50% of the 450 medtech companies based here are indigenous.”

Senior business leaders were asked to identify the current number of employees required to meet their current skills demand, as well as the forecasted number of employees required in each function of their organisation up to 2020. An estimated 4,000 additional jobs are planned by 2020, Key areas are: Regulatory 54 additional jobs (43% increase from 2016) Quality 287 additional jobs (17% increase from 2016)1

The sector is, by its nature, highly regulated; all disciplines involved in the design, manufacture and distribution of a medical device are controlled by medical device regulations. Given the unique need for regulatory affairs knowledge and understanding at all stages of a medical device product lifecycle there is a strong need for the medical technology industry to have available to it appropriate courses to satisfy this information and skills need. The Forfás National Skills Bulletin 20162 further supports this need as it identified a skills shortage for regulatory professionals and quality control engineers

1 Source: Irish Medtech Association Skills Needs Assessment Stakeholder Survey. "Future skills needs analysis for the medical technology sector in Ireland to 2020"​

Further Study

Following completion of the one year Level 8 Certificate in Medical Technology Regulatory Affairs and Operations (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 NUI Galway and ATU Sligo.

Did you know?

The course meets a skills gap as highlighted in the SOLAS “Difficult to fill vacancies” survey of 2021 where 46% of employers expressed difficulty in filling roles related to manufacturing processes, validation, quality and regulatory, as well as compliance and regulatory affairs specialists (https://www.solas.ie/f/70398/x/67ace347ad/solas-difficult-to-fill-vacancies-survey.pdf).  Future Skills gaps highlighted by the Irish Medtech Skillnet in 2020 highlighted manufacturing , quality and regulatory as areas of future skills shortages (https://www.ibec.ie/-/media/documents/irish-medtech-future-skills-needs-analysis.pdf). 

Alumni

A recent study by NUI Galway & ATU Sligo  and published in Regulatory Focus  found that our Medtech courses are valuable for CPD and upskilling within the industry as over 90% of students/graduates were promoted in their own organisations/moved to other positions while completing the course or after graduation (  https://www.raps.org/news-and-articles/news-articles/2021/4/value-of-an-ra-qualification-in-continuous-profess).
 

Programme Fees

Fees

 

Total Programme Fees:

€4,500

Non-EU Fees

 

Non-EU Programme Fees:

€ TBC per annum ( were €8k in 2021/22)

If an applicant is Employer funded and their Employer is a Member of the Next Level Skillnet, companies can avail of reduced Fees. Fees will be €1,350 per Semester – a discount of €900 per Semester. Total Fees reduced by €1,800 from €4,500 to €2,700.*

If an applicant is Employer funded but their Employer is not a Member of the Next Level Skillnet,companies can still avail of reduced Fees. Fees will be €2,025 per Semester – a discount of €225 per Semester. Total Fees reduced by €450 from €4,500 to €4,050*

* Subject to confirmation of funding support for each semester. See next level skillnet qualifying criteria at http://nextlevel.ie/at-a-glance/employee/