The Level 8 Higher Diploma in Medical Technology Regulatory Affairs and Quality 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 regulatory experts from industry, and industry practitioners. 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 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 and quality environment within the medical technology and pharmaceuticals industry sectors.
3. Completing this course will open up a new opportunities and career paths, in quality and/ or regulatory affairs, in both Irishbased and international Medical Technologies and Pharmaceuticals enterprises.