Technological University of the Shannon

Process Validation and Regulatory Affairs (Medical Technology) – MSc

Many companies operate in highly regulated areas where the demand for dynamic validation engineers, effective quality management systems and regulatory compliance leaders is growing in the Medical Technology industry. The aim of the Level 9 Taught Masters of Science in Process Validation and Regulatory Affairs is to equip learners with competence in the appropriate legal, compliance and industry operational standards. The programme 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.

Critical thinking, problem solving, decision making, professionalism and management techniques will be key areas covered by the programme.