Course Name |
Medical Technology Regulatory Affairs |
Course Provider |
ATU - Galway Campuses |
Alternative Provider(s) |
ATU - Atlantic Technological University |
Course Code |
GA_SMRAG_L08 |
Course Type |
Postgraduate |
Qualifications |
Award Name | NFQ Classification | Awarding Body | NFQ Level |
Higher Diploma (Level 8 NFQ)
More info...
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Major |
Atlantic Technological University |
Level 8 NFQ |
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Apply To |
Course provider |
Attendance Options |
Full time, Daytime |
Location (Districts) |
Galway City |
Qualification Letters |
HDip |
Enrolment and Start Dates Comment |
Start Date: September 2023. TBC. |
Application Date |
Expand+Postgraduate Applications
Details on how to apply for Postgraduate Courses at ATU
Applications for programmes commencing in September 2023 are NOW OPEN.
Click on "Application Weblink" below.
If you have any queries or need any assistance ...
Hide-Postgraduate Applications
Details on how to apply for Postgraduate Courses at ATU
Applications for programmes commencing in September 2023 are NOW OPEN.
Click on "Application Weblink" below.
If you have any queries or need any assistance applying for a postgraduate course please contact our Graduate Studies and Professional Development (GSPD) team who will guide you through the process.
Email: learn.galwaymayo@atu.ie and reference the course you're interested in applying for in your message.
Are you an international student? Please contact the International Office for more information:
Tel: +353 (0)91 74 2149/2211
Email: international.galwaymayo@atu.ie
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Application Weblink |
Web Page - Click Here |
Duration |
1 year full-time. Blended learning. |
Link to Course Fee |
Web Page - Click Here |
Entry Requirements |
Expand+Course participants must have at least a level 8 qualification 240 credits (4 year hons degree) prior to acceptance onto this course. It is especially suitable for participants intending to work in regulatory affairs and quality related roles. .
P...
Hide-Course participants must have at least a level 8 qualification 240 credits (4 year hons degree) prior to acceptance onto this course. It is especially suitable for participants intending to work in regulatory affairs and quality related roles. .
Places will be given to those who are most eligible for the programme.
Eligibility criteria
To confirm eligibility on Springboard courses, please go to https://springboardcourses.ie/eligibility
The following documents must be attached to your application; (Application cannot be processed without these documents attached, once all documents are received online, with your application, status will be updated to pending. Places will be given to those who meet the eligibility criteria and are most eligible for the programme)
1. If you are unemployed you need to send a copy of your jobseeker benefit/allowance slip, or letter from social welfare office. – MUST BE DATED within 2 weeks of the start date of the course
2. Copy of transcripts to support your academic history – Proof of Level 8 – 240 credits (4 year degree)
3. CV
4. Proof of Address – Utility Bill/P60 etc.
5. Proof of identification – Passport/Drivers Licience
6. Visa Requirements/Stamp 4 etc.
7. Proof of PPS number
8. Proof of residence – dates must show 3 years residence prior to start of course. Proof for each year 2019, 2020, 2021., or 2020, 2021, 2022, etc.
Irish Medtech Springboard will contact you closer to start date of course (within 4 weeks of start to collect this data prior to enrolment of course)
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 ATU, to facilitate this level 8 award; Higher Diploma Medical Technology Regulatory Affairs Professional.
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Number of Places |
30 |
Course Summary |
This course will provide a practical solution for participants to gain practical & theoretical understanding of regulatory affairs activities for the Medical Technology sector. |
Course Content |
Expand+Overview
The Higher Diploma Medical Technology Regulatory Affairs Professional will be delivered and accredited through Atlantic Technological University (ATU) Galway.
This programme is funded through the Irish Medtech Springboard.
It is a 60...
Hide-Overview
The Higher Diploma Medical Technology Regulatory Affairs Professional will be delivered and accredited through Atlantic Technological University (ATU) Galway.
This programme is funded through the Irish Medtech Springboard.
It is a 60 credit NFQ Level 8 award based on the need to provide an ongoing skilled workforce to the Medical Device sector. Especially with the introduction of the new European Medical Device Regulation (MDR) coming into effect in May 2021 and the In Vitro Diagnostic Device Regulation (IVDR) implementation due in 2022, this course is designed to ensure participants will be educated in these new requirements while also understanding the Global regulatory framework.
This course will provide a practical solution for participants to gain practical & theoretical understanding of regulatory affairs activities for the Medical Technology sector.
Programme Supports Medtech industry by ensuring that students are well informed and educated in-depth on the specific regulations and associated safety & performance application for medical devices & IVD’s. Within one academic year, you will be considered a major asset to the regulatory profession and immediately integrate into the business.
This programme includes a blended learning approach with 10 contact hours on a weekly basis over 3 semesters resulting in 60 ECTS. Continued assessment methodology will be applied with course advancement linked to achieved interaction & results.
As an introduction the current Fundamentals in Regulatory affairs will be provided, this is a pre-requisite and will provide participants with the basic understanding required to proceed to advanced regulatory modules. Also, those who have already completed this course can obtain an exemption.
The ultimate aim of the programme is intended to provide a qualification for graduates (employed/unemployed) to undertake or progress in a Medical Technology Regulatory affairs career.
The need for the programme was inspired by a specific demand from industry to meet the clear need to upskill/hire personnel for the regulatory affairs function. In addition, participants who want to aspire to management level within the Regulatory Affairs profession can further develop their skills and offer immediate value to the business on programme completion.
Carefully selected course tutors will bring a blend of Industry, Regulatory Authority and Academic expertise with current teaching methods and on-line systems applied.
Course Details
Over two Semesters participants will be tutored by industry and regulatory body experts on the major global regulations and appropriate application framework. They will be equipped to better support their company in achieving market approval & post approval maintenance through the practical learning this course provides. The following modules will be delivered, 3 in Semester 1 & 4 in Semester 2 with ongoing assessment applied. There is no final exam. Participants must pass each module.
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Subjects Taught |
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 |
Careers or Further Progression |
Expand+Job Opportunities
The knowledge gained in this programme is critical to all technical roles in the Life Science Sector. Research & Development Engineers along with Manufacturing Eng., Quality & Testing Specialists and Regulatory Professionals must...
Hide-Job Opportunities
The knowledge gained in this programme is critical to all technical roles in the Life Science Sector. Research & Development Engineers along with Manufacturing Eng., Quality & Testing Specialists and Regulatory Professionals must understand what Global regulations need to be met & how the framework is applied. There is no other programme that equips participants with this up to date knowledge and having this qualification on your cv will reduce the burden on industry to train you on-site.
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Further Enquiries |
If you have any queries please email:
Name: Michelle Quain
Irish Medtech Springboard course co-ordinator
Michelle.quain@ibec.ie
M: 087-1906802
Name: Carmel McGrath,
Course Director & Adjunct Lecturer ATU
e: carmel@associate.atu.ie
Tel: 087-4185458 |
Course Web Page |
Web Page - Click Here |
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