Medical Technology Regulatory Affairs Professional (Medical Technology Regulatory Affairs Professional)

Irish Medtech Association (Medtech RA 2)
Key Programme Details
Award

Higher Diploma Medical Technology Regulatory Affairs Professional

NFQ Level

Level 8 About NFQ

Delivery Method

Online, Classroom, Blended

Mode

Full Time

ECTS Credits

60

General Information
Contact

Trish Breen

Email

trish.breen@ibec.ie

Phone

087 715 7967

Address

Ibec 84-86 Lower Baggot Street Dublin 2

Role

Project Manager

Important Dates
Application Deadline

10/09/2021

Start Date

27/09/2021

End Date

31/08/2022

About this Course

Higher Diploma Medical Technology Regulatory Affairs Professional is a 60 credit NFQ Level 8 award is based on need to provide a skilled workforce to implement and support the medical device sector with the new Medical Device Regulation (MDR) coming into effect in May 2021 and the in vitro Diagnostic Device Regulation (IVDR) implementation due in 2022. The course participants must have at least a level 8 qualification or equivalent work experience prior to acceptance onto a course. It is suitable for participants intending to work in regulatory affairs roles.

The course will:
Provide a practical solution for participants to gain practical & theoretical understanding of regulatory affairs activities for the Medical Technology sector.
Support Medtech industry by ensuring that students are well informed and educated in-depth on the specific regulations and associated application
Provide a programme of ongoing assessment with course advancement linked to achieved results.
Incorporate practical industry experience will ensure that students can immediately apply knowledge and competence.
This will include a blended learning approach with 10 contact hours on a weekly basis over 3 semesters resulting in 60 ECTS.

Entry Requirements

Participants must have at least a level 8 qualification (240 ects/credits) prior to acceptance onto a course.
Exact academic eligibility requirements will be determined by individual providers and may depend on the nature of the course.
As under Springboard+, other eligible participants will include the unemployed, returners and those in employment.

Places will be given to those who are most eligible for the programme.

The unemployed and returner categories will have the full cost of the course covered, while those in employment will pay 10% of the cost of the fee.
All employed participants will be required to pay 10% of the overall costs of the programme.
10% fee cost is €690.00 per person.

Long Description

Higher Diploma Medical Technology Regulatory Affairs Professional is a 60 credit NFQ Level 8 award is based on need to provide a skilled workforce to implement and support the medical device sector with the new Medical Device Regulation (MDR) coming into effect in May 2021 and the in vitro Diagnostic Device Regulation (IVDR) implementation due in 2022. The course participants must have at least a level 8 qualification or equivalent work experience prior to acceptance onto a course. It is suitable for participants intending to work in regulatory affairs roles.

The course will:
Provide a practical solution for participants to gain practical & theoretical understanding of regulatory affairs activities for the Medical Technology sector.
Support Medtech industry by ensuring that students are well informed and educated in-depth on the specific regulations and associated application
Provide a programme of ongoing assessment with course advancement linked to achieved results.
Incorporate practical industry experience will ensure that students can immediately apply knowledge and competence.
This will include a blended learning approach with 10 contact hours on a weekly basis over 3 semesters resulting in 60 ECTS.

As an introduction the current Module Fundamentals of Regulatory affairs will be provided such that those that have already achieved this course can get an exemption. It is intended to provide a qualification for graduates (employed/unemployed) to undertake a career in Medical Technology Regulatory affairs.
The need for the programme was inspired by a specific demand from industry (reference Appendix 1 MDR impact Survey) to meet the clear need to upskill/hire personnel to the regulatory affairs function. In addition, participants who want to aspire to management level within the Regulatory Affairs profession can further develop their skills offer immediate value to the business on programme completion

Modules:
1. Fundamentals in Regulatory Affairs
2. Quality Management, Regulatory Strategy & Audit Practices
3. Design Controls, Risk Management & Clinical Studies for Medical Technology Industry
4. Medical Technology Regulations for the U.S. Market
5. Medical Technology Regulations for the EU Market
6. Major Global Markets
7. Medical Device Safety Monitoring and Incident Reporting

Why Choose This Course

Higher Diploma Medical Technology Regulatory Affairs Professional is a 60 credit NFQ Level 8 award is based on need to provide a skilled workforce to implement and support the medical device sector with the new Medical Device Regulation (MDR) coming into effect in May 2021 and the in vitro Diagnostic Device Regulation (IVDR) implementation due in 2022.

The course participants must have at least a level 8 qualification (240 ects/credits) onto a course.
It is suitable for participants intending to work in regulatory affairs roles.
Accredited by GMIT

Timetable Info

Blended, with virtual & Live classrooms, live weekly tutorials, and weekly pre-recordings.
Schedule to be advised

Delivery Location

Galway location for any classroom lectures TBC

Delivery Notes

Blended

Admissions Contact Details
Contact Person

Trish Breen

Address

Ibec 84-86 Lower Baggot Street Dublin 2

Phone

087 715 7967

Email

trish.breen@ibec.ie

Application Procedures

Participants must have at least a level 8 qualification (240 ects/credits) prior to acceptance onto a course.
Exact academic eligibility requirements will be determined by individual providers and may depend on the nature of the course.
As under Springboard+, other eligible participants will include the unemployed, returners and those in employment.
The unemployed and returner categories will have the full cost of the course covered, while those in employment will pay 10% of the cost of the fee.

All employed participants will be required to pay 10% of the overall costs of the programme. Cost is €690.00 per person.

The following documents must be attached to your application; (Application cannot be processed without these documents attached)
1. If you are employed – a letter from your employer / most recent payslip
1. If you are a homemaker you need to have a letter confirming this, signed by commissioner of oath.
1. If you are unemployed you need to send a copy of your jobseeker benefit/allowance slip, or letter from social welfare office.
2. Copy of transcripts to support your academic history - Proof of L8/L9 - 240 credits - transcripts
3. CV

Applications cannot be processed without receipt of above documents.

NOTE: By applying to this course, through the Irish Medtech Springboard, you are agreeing to your data being shared with the relevant staff and trainers within the Irish Medtech Springboard, and GMIT, to facilitate this level 8 award.