Medical Technology Regulatory Affairs Atlantic Technological University

Overview

The  Medical Technology Regulatory Affairs programme from the Atlantic Technological University will enable Regulatory Affairs personnel in the Medical Technology industry to understand all current device and diagnostic regulations and to develop the skills necessary to address and prepare for the ever-changing global environment of regulatory affairs. Upon successful completion of the programme, participants receive an MSc award at NFQ Level 9.

The impetus for the development of this specialist programme emerged from industry needs and the content has been developed jointly by University of Galway and ATU Sligo in conjunction with an industry taskforce comprised of regulatory experts from Irish Medtech’s Regulatory and Quality Working Group. The development of the programme is supported by the Irish Medtech Skillnet and contracting organisation, the Irish Medtech, the Ibec group that represents the Medical Technology sector.

Careers

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.

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.