Medical Technology Regulatory Affairs & Quality

The proposed course will link the existing regulations to regulatory requirements and how those requirements are executed across the medical device lifecycle; for example, how to develop technical documentation for regulatory submissions (regulatory affairs professionals); how to perform vigilance post-market surveillance requirements (Vigilance Specialist); core quality management standards and requirements (QA or Compliance Specialist); and testing requirements to demonstrate the safety and efficacy of a medical device (R&D Engineer).

3 GOOD REASONS TO STUDY THIS COURSE
1. Regulatory affairs and quality 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 and business activities.

2. This programme will equip graduates with essential knowledge and skills to work in a regulatory affairs or quality role, or within a support function, e.g., Market Vigilance, Risk Mgmt., Operations Quality, Validation & Calibration, Auditing, Sterilisation, etc., within the medtech industry.

3. Completing this course will open up a new opportunities and career paths, in quality and/ or regulatory affairs, in both Irish and international medtech enterprises.

Minimum Entry Requirements
Graduates who have a Level 7 qualification in a relevant area of science, engineering, or technology are eligible to apply for this programme. 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 be considered. Candidate interviews may be used. International students, whose first language is not English, will be required to prove their English competency (e.g., IELTS English language proficiency of 6.5 [with no band less than 6.0 in each element of the test]) or equivalent, and will also need to provide evidence of their oral communication skills at interview. In addition, they will need to provide evidence of having relevant experience in research (laboratory and/or computational desk-based research).

Closing Date: 17th August 2023

2 years, part-time, online distance learning (100% online).

Career Opportunities
This programme has been specifically designed to meet the growing requirements of medical technology companies in filling regulatory and quality assurance roles. 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, for the west and north west. The Irish Medtech Association (IMA) Skillnet asked senior medtech industry executives to identify the current number of employees required to meet current skills demand, and to forecast the number of employees required in medtech organisations up to 2020. The Industrial Development Authority (IDA)(2021) has estimated that there are 32,000 people working in medical technologies jobs, and the IMA (2018) forecast a 43% increase in staff numbers in regulatory affairs functions, and 17% in quality roles.