28/09/2020

12/10/2020

31/08/2021

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.

Participants must have at least a level 8 qualification 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.
10% fee cost is €690.00 per person.

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:
Fundamentals in Regulatory Affairs: Fundamentals in Regulatory Affairs
Quality Management & Technical Writing: Quality Management & Technical Writing
Clinical Evaluation Masterclass series: Clinical Evaluation Masterclass series
Design & Device Evaluation: Design & Device Evaluation
U.S. Regulations: U.S. Regulations
EU Regulations & Mutual Recognition agreements: EU Regulations & Mutual Recognition agreements
EU Regulations & Mutual Recognition agreements: EU Regulations & Mutual Recognition agreements
Global Regulations & MDSAP: Global Regulations & MDSAP
Post Market Responsibilities incl. EUDAMED: Post Market Responsibilities incl. EUDAMED
Regulatory Affairs Business Strategy: Regulatory Affairs Business Strategy

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 2020 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.
Accredited by GMIT

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

Galway location for any classroom lectures TBC

Blended

Shane Beirne

Ibec 84-86 Lower Baggot Street Dublin 2

01- 6051677

shane.beirne@ibec.ie

Participants must have at least a level 8 qualification 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; (Whichever document is relevant to your status)
1. If you are employed – a letter from your employer / P60 confirming you are employed.
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.
3. CV