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

National University of Ireland, Galway (1MTD4 (NUI Galway code) / SG_SMEDO_E08 (IT Sligo) )
Key Programme Details
Award

Certificate

NFQ Level

Level 8 About NFQ

Delivery Method

Online

Mode

Part Time

ECTS Credits

40

Department

Science

General Information
Contact

Olivia McDermott

Email

Olivia.McDermott@nuigalway.ie

Phone

087-2205256

Address

Room 222 Orbsen Building,
NUI Galway
University Road
Galway
H91 TK33

Role

Course Coordinator

Important Dates
Application Deadline

18/09/2020

Start Date

28/09/2020

End Date

28/05/2021

About this Course

The course is intended to increase the skills and knowledge base of those with activities or interest 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 which is customized to meet the exact needs of the clients.
The programme aims are to:
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 operations, 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.

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.

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 candidate who hold a Level 7 primary degree in a non-technical subject, and who have at least five years medical technology industry experience in Operations/Quality and / or regulatory affairs will be considered.
Candidate interviews may be used to assess candidate's suitability for the programme.

Long Description

The course is intended to increase the skills and knowledge base of those with activities or interest 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 which is customized to meet the exact needs of the clients.
The programme aims are to:
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 operations, 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.

Why Choose This Course

The Irish MedTech Association Skillnet commissioned a national MedTech Skills Report to 2020 published in May 2017. 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 organization up to 2020. An estimated 4,000 jobs will be added by 2020, with a 43% increase in staff numbers in the regulatory affairs functions and 17% in Quality roles.

The impetus for the development of this specialist programme emerged from industry needs and content has been developed in conjunction with a taskforce comprising regional skills Northwest and West MedTech companies such as Boston Scientific, Medtronic, BD, Cook , TE (Creganna), Merit Medical, Integer and other Siemens MedTech industry representatives.
The associated with this programme have been engaged in very active discussions over the last year in relation to the planned rollout of NUI Galway and Next Level Skillnet Level 8 programme in Regulatory Affairs and Operations working together since early 2018 on the Level 9 programme. There is currently no equivalent programme on offer at Level 8.


The level 8 Certificate in Medical Technologies Regulatory Affairs and Operations aims to support national development in economic, social and cultural terms and furthermore to deliver training which is customized to meet the exact needs of the clients.
There remains a challenge for medical technology companies in sourcing suitably qualified regulatory professionals. This is clear from the “Action plan for Jobs 2015” Forfás report. The on-going requirement for regulatory professionals is identified in the EGFSN Guidance for HE providers on current and future skills needs of enterprise for medical devices.

Career Opportunities

NUI Galway have been working closely with the Regional Skills Forum (RSF) since 2016 in addressing the skills needs of industry. Data collected by the RSF is being used to support the development of new programmes and ensure the requirements of local and national employers are being met.
The Skills Audits completed by the RSF in the West are being used to further inform applications to Springboard from NUI Galway. In addition, local, national and international reports influence the programmes proposed. NUI Galway have also engaged with data made available from bodies such as Intreo who provide valuable insight into information related to the unemployed. The programmes proposed take into consideration the needs of those seeking employment and those in employment.
From collaborating with local and regional employers, it was determined that employers are struggling to fill positions in the following areas:
• Medical Technologies, Pharmaceutical and biopharmaceutical
• Software Development
• Information Technologies (ICT)
• Process Engineering
The RSF Manager firmly believes that providing training in the above areas would contribute significantly to improving the employment prospects of a considerable number of people in the region. In addition to filling vacant positions, the above programmes would support employees wishing to progress in their career.

Timetable Info

To be confirmed.

Delivery Location

All lectures for this programme are delivered as live online lectures. Attendance at these is not mandatory and lectures are recorded for the convenience of participants to listen to in their own time.

Delivery Notes

Online

Admissions Contact Details
Contact Person

Terry Smith

Address

Room 215 Orbsen Building,
NUI Galway
University Road
Galway
H91 TK33

Phone

0872624004

Email

terry.smith@nuigalway.ie

RPL Information

Applicants wishing to apply for RPL must indicate this on their Springboard application.

Application Procedures

All Springboard applications must be submitted through the Springboard website www.springboardcourses.ie

Media
IT Sligo Online student experiences

Listen to some of IT Sligo's current and past online students talking about their experiences studying online.

https://www.itsligo.ie/success-stories/


Certificate Course website

Information on Course, module information, and career opportunities

https://www.itsligo.ie/courses/certificate-in-medical-technology-regulatory-affairs-and-affairs-online/