Medical Technologies Regulatory Affairs & Operations

The impetus for the development of this specialist programme emerged from industry needs, and the content has been developed in conjunction with a taskforce comprised of regulatory experts from industry, industry practitioners and representatives from the regional skills fora, west and north-west.

The Irish MedTech Association (IMA) Skillnet invited senior medtech industry executives to identify the current number of employees required to meet current skills demand, as well as forecasted number of employees required in medtech organisations up to 2025. An estimated 4,000 additional medical technologies jobs are expected to be added by 2025, with a projected 5.5% year-on-year growth.

3 GOOD REASONS TO STUDY THIS COURSE
1. Regulatory affairs and operations professionals at all career and experience levels are involved in activities throughout the product lifecycle, and in bridging the gap between regulatory-related functions, and organisation of business functions.

2. This programme will equip graduates with essential knowledge and skills to work in a regulatory affairs and other support roles, e.g., Operations Quality, Validation and Calibration, Auditing, Market Vigilance, Sterilisation, etc., within the medical technologies industry sector.

3. Completing this programme will open up new opportunities and career paths, in regulatory affairs and/or operations in Ireland based and international medical technologies and pharmaceutical enterprises.

Minimum Entry Requirements
Graduates with a Level 7 qualification or higher in a relevant area of science, engineering or technology are eligible, and applications from candidates who hold a Level 7 primary degree in a non-technical subject, and who have at least five years' medical technology industry experience in quality and /or regulatory affairs will also be considered. Candidate interviews may be used to assess candidates' suitability for the programme. Students applying on the basis of formal qualifications and supplementary accredited prior learning (APL) for core pre requisites will be required to submit full details and references to the Programme Board for consideration of educational equivalencies.

Prior experiential learning will be assessed using guidelines recommended by the Academic Council of IT Sligo and NUI Galway. All applicants whose first language is not English must present a qualification in the English language, e.g., IELTS (no less than 6.5 in ANY component); TOEFL (no less than 88 in ANY component); and Pearson (no less than 61 in ANY component).

NOTE: Language tests must be undertaken no more than two years prior to commencement of the course.

CLOSING DATE: 15th August 2023

1 year, part-time distance learning (100% online).

Career Opportunities
This programme will equip graduates with essential knowledge and skills to work in a regulatory affairs or quality environment within the highly successful and growing Irish medical technology industry sector, where over 32,000 people are currently employed. It has been specifically designed to meet the growing requirements of medical technology companies in filling regulatory and quality assurance roles.