New quality and regulatory affairs programme for medtech centre

NUI Galway and IT Sligo, in collaboration with ulearning Skillnet have announced a new programme designed to address the skills shortages in the medtech sector in the areas of quality and regulatory affairs. The NFQ Level 8 certificate in medical technology regulatory affairs and quality programme (30 ECTS ) is a one year part-time online programme, and is designed in order that candidates can complete the course while in employment.

Students completing the certificate can also progress onto a Level 8 higher diploma award. The content has been developed in conjunction with a taskforce comprising regulatory experts from industry, industry practitioners, and representatives from the regional skills fora.

The course provides students with an introduction to the core elements of the medical device product development lifecycle and the associated role of a medical technology regulatory affairs and/or quality professional.

The medical technology sector employs more than 29,000 people in Ireland and is highly regulated. The industry needs to have available to it appropriate training courses to satisfy this information and skills need. The IMA report (2017 ) has estimated that 4,000 additional medical technologies jobs will be added by 2020, with a 43 per cent increase in staff numbers in the regulatory affairs functions and 17 per cent in quality roles.

The programme shall be made available online using a combination of distance-learning/e-learning technologies, with some face to face workshops, for an overall blended learning approach.

The programme is open to all those who have a Level 7 qualification in a relevant area of science, engineering, or technology. Applications from candidates who hold a Level 7 primary degree in a non-technical subject, with at least five years' relevant medical technology industry experience, will be considered.

Ulearning skillnet shall subsidise eligible candidate fees by 33 per cent. The programme commences on September 8 2017.

For further information contact the programme directors, Prof Terry Smith at [email protected] or Mary Butler at [email protected].


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