Medical Technology Regulatory Affairs - Sligo

Developed jointly by the University of Galway and ATU Sligo and in conjunction with an industry taskforce comprised of regulatory experts from the Irish Medtech Association (IMA) Regulatory and Quality Working Group, the course is supported by the Irish Medical Devices Association Irish Medtech Association (IMA) Skillnet.

Given the evolving nature of international regulations, a regulatory affairs professional must continually grow their knowledge and skills to be effective and to advance in their careers.

Modules

Introduction to EU Medical Technology Regulatory Affairs
Introduction to US Medical Technology Regulatory Affairs
Technical Report Writing
EU Medical Technology Regulatory Affairs- Advanced
US Medical Technology Regulatory Affairs Advanced
Risk Management, Labelling and Promotion
Global Medical Technology Regulatory Affairs Part 1
Clinical Evaluation Reporting
Quality Management System
Global Medical Technology Regulatory Affairs Part 2
Design Assurance, Sterilisation and Biocompatability
Post Market Surveillance
Medical Technology Regulatory Affairs Dissertation

Applicants require a Level 8 primary degree in a science/ engineering subject related to the life sciences.

Applications for online programmes are accepted on the atu sligo website.

All programmes advertised will run subject to sufficient student numbers.

ATU sligo online has two intakes per year, the main one being in September with a smaller listing of programmes for January. For confirmation on start dates check www.itsligo.ie/online

For September, applications open from 1st February each year. Closing date for receipt of applications is 31st august.

For January, applications open from 1st November each year. Closing date for applications is mid-January.

The online application form requires personal details, previous qualifications, professional accreditations, employment history and a personal statement. We recommend collating all the necessary paperwork i.e. Transcripts of previous qualifications, academic certificates before you submit an application.

Once submitted, our admissions team will contact you to confirm eligibility and request copies of any previous qualifications.

Academic staff review every application and approve eligible candidates for the programme.

Admissions team will notify you if you are accepted onto the course and will request deposit to confirm your place.

Places are limited, so please apply early.

Assessment of students will be through continuous assessment of each module, which will include written assignments, workshop-based problem solving, and open-book exams using multiple choices, matching questions as well as short and long answer questions. The Research Project thesis will also be assessed.

90

2.5 years part-time, online.

On-Campus Attendance
One optional workshop, per semester.

EU students: MSc €12,000. Individual modules €900. Dissertation €2,500.

Non EU fees: €18,000 for MSc

Anyone living / working outside of Ireland and the EU for over 3 years pays non-EU Fees

http://www.nuigalway.ie/student-fees/international/​

Contact the college for the next start date.

Career Opportunities
This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs environment within the highly successful and growing Irish Medical Technology industry sector.

The Irish Medical Devices Association (IMDA) states that the medical technology sector employs over 25,000 people, with 18 of the world's top 25 medical technology companies maintaining a base in Ireland and a further 50% of the 300 Medtech companies being indigenous. The sector is expected to continue to grow as stated in December 2014 by the Director of the IMDA Sinead Keogh: "IMDA's latest survey shows that confidence within the sector is improving steadily…. with nearly half of companies more confident now than they were three months ago and nearly half planning to hire new staff.

Regulatory Affairs within the medical technology products sector is a relatively young, multidimensional profession that is international in scope. Operationally, a Regulatory Affairs professional is responsible for assuring that pertinent government obligations, market-driven demands, and evolving scientific conventions are understood and addressed by various stakeholders of the medical and health care system. Given the evolving nature of international regulations, a regulatory affairs professional must continually grow their knowledge and skills to be effective and to advance in their careers.

Regulatory professionals at all career and experience levels are involved in activities throughout the product lifecycle, and most are involved to some degree in bridging the gap between regulatory-related functions and organization and business activities.