Certificate in Medical Technology Regulatory Affairs and Operations (Certificate in Medical Technology Regulatory Affairs and Operations)

National University of Ireland, Galway (SG_SMEDO_E08)
Key Programme Details
Award

NFQ

NFQ Level

Level 8 About NFQ

Delivery Method

Online

Mode

Part Time

ECTS Credits

35

Department

Science & Engineering

General Information
Contact

Olivia McDermott

Email

olivia.mcdermott@nuigalway.ie

Phone

0872205256

Address

NUI Galway, .University Road

Role

Course Director

Important Dates
Application Deadline

19/08/2022

Start Date

19/09/2022

End Date

25/05/2023

About this Course

The course is intended to increase the skills and knowledge base of those with activities or interests in Regulatory Affairs and Operations and to increase the pool of such people available to the medical device industry. It will provide a level 8 qualification in Regulatory affairs/Operations that will form both an introduction for new or proposed entrants to the area and additional skills and knowledge to those working in the area. The Level 8 programme in Medical Technology Regulatory Affairs and Operations aims to support national development in economic, social and cultural terms and furthermore to deliver training that is customised to meet the exact needs of the clients.
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). A recent study by NUI Galway published in Regulatory Focus found that 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). This course was developed in conjunction with industry partners (Medtronic, Boston Scientific, Cook Medical, TE Connectivity, Merit Medical to name a few) in the Medical Device Industry to fulfil a skills gap and support education in the upcoming changing Global and European Regulatory environment.

The programme aims are to 1. Provide participants with a fundamental grounding in medical device regulatory structures and requirements. 2. 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 operations, quality assurance and/or regulatory affairs functions and to upskill medical technology professionals in the regulatory framework in their existing roles. 3. Foster the participant's intellectual development in academic and industrial environments. 4. Develop participant's skills to work and communicate with appropriate autonomy and effectively through various media.
PROGRAMME OBJECTIVES are to produce graduates with the essential breadth and kind of knowledge, skillset, 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.

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 of medical technology industry experience in Operations/Quality and/or regulatory affairs will be considered. Candidate interviews may be used to assess candidates' suitability for the programme.

Long Description

The course is intended to increase the skills and knowledge base of those with activities or interests in Regulatory Affairs and Operations and to increase the pool of such people available to the medical device industry. It will provide a level 8 qualification in Regulatory affairs/Operations that will form both an introduction for new or proposed entrants to the area and additional skills and knowledge to those working in the area. The Level 8 programme in Medical Technology Regulatory Affairs and Operations aims to support national development in economic, social and cultural terms and furthermore to deliver training that is customised to meet the exact needs of the clients.
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). A recent study by NUI Galway published in Regulatory Focus found that 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). This course was developed in conjunction with industry partners (Medtronic, Boston Scientific, Cook Medical, TE Connectivity, Merit Medical to name a few) in the Medical Device Industry to fulfil a skills gap and support education in the upcoming changing Global and European Regulatory environment.

The programme aims are to 1. Provide participants with a fundamental grounding in medical device regulatory structures and requirements. 2. 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 operations, quality assurance and/or regulatory affairs functions and to upskill medical technology professionals in the regulatory framework in their existing roles. 3. Foster the participant's intellectual development in academic and industrial environments. 4. Develop participant's skills to work and communicate with appropriate autonomy and effectively through various media.
PROGRAMME OBJECTIVES To produce graduates with the essential breadth and kind of knowledge, skill 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.

Career Opportunities

Medical Device Regulatory Professional, Quality Engineer, Operations Engineer, Market Vigilance/Customer complaints
Sterilisation personnel

Delivery Location

Online

Delivery Notes

Online

Admissions Contact Details
Contact Person

Olivia.McDermott@nuigalway.ie