Process Validation and Regulatory Affairs (Medical Technology) Technological University of the Shannon

Overview

The  Process Validation and Regulatory Affairs (Medical Technology)  programme at  Technological University of the Shannon  will enable an understanding of all current applicable regulations, quality management systems and effective process validation requirements. Learners will have the knowledge and skills to audit all, or part of, the organisation’s formal Quality Management systems. Acquire the ability to objectively evaluate evidence generated by systems and processes against clearly defined criteria and determine the effectiveness of these systems and processes; ensuring that learners will develop skills to address and prepare for the ever-changing environment of regulatory affairs in the Medical Technology sector.

Career Opportunities

This programme has been designed to meet the growing requirements of pharmaceutical companies in filling Quality, Validation, Management, Auditing, Compliance, Legal and Regulatory affairs. The motivation for developing this programme emerged from industry needs, gaps in education programms and a lack of graduates in the hiring pool. The content has been developed jointly by TUS in conjunction with industry consultants and industry practitioners from companies such as Abbott, BD Medical, Johnson & Johnson, Regeneron, Edward Science, Boston Scientific etc.

There are multiple roles a graduate from the programme can seek in disciplines such as Validation, Management, Auditing, Compliance, Legal and Regulatory affairs.

• Regulatory Affairs Specialist / Engineer / Manager
• Verification and Validation Specialist / Engineer /Manager
• Quality and auditing Specialist / Engineer / Manager
• Compliance Specialist / Engineer / Manager
• Verification and Validation Specialist / Engineer /Manager
• Manufacturing or Process Engineer/ Manager