Certificate in Regulatory Affairs Quality Management and Strategy

  • Certificate in Regulatory Affairs Quality Management and Strategy 
  • 10
  • Minor Award Level 9
  • 12 WEEKS
  • Blended – combination of onsite and online learning
  • Overview
  • Subjects
  • Entry Requirements
  • Fees
  • How to apply
  • Contact us


The aim of this module is to provide learners with a detailed understanding and requirements of a quality management system and how to design this under the CFR 820 or ISO13485 headings, as well as compliance assessment. The module will also examine strategic issues affecting the commercial maintenance of a medical technology product post-launch and an understanding of the skills required to control regulatory affairs departments, customer feedback and complaints.


Regulatory affairs quality management and strategy

Entry Requirements

All applicants will be considered on a case-by-case basis. Lifelong Learning reserves the right to require applicants to attend for an interview to determine their suitability for the programme



How to Apply

Application Form »

Contact us

Phone: (059) 9175280
Email: lll.cw@setu.ie