Director of Quality and Regulatory

Posted 22 August 2023
Job type Permanent
Contact NameLouise Cleland

Job description

My client is the largest medical device consultancy in Europe, focusing on a wide variety of sectors including diagnostics, medical devices, software as a medical device, surgical & combination products just to name a few.


This is a great opportunity for someone looking to be apart of a family and to help shape the development of the team and the positioning QARA capabilities both internally and with clients. You will work within a diverse and inclusive environment, where everyone genuinely wants to see you succeed and develop in your career.


Please see below:



  • Responsible for growing and leading a high performing team of QA and RA professionals
  • Drive QARA capabilities with clients
  • Provide support to global clients in developing regulatory strategies and support the project teams in creating technical documentation
  • Update, maintain and continually improve the QMS
  • Build relationships with stakeholders and drive commercial awareness to medtech within the business
  • 60/40 split to RA and QA activities
  • Support client audits



  • Bachelor's degree in a scientific field
  • Extensive experience (approx. 10-20 years) in regulatory compliance for medical devices for EU/FDA markets
  • Strong experience with ISO13485 & FDA QSR QMS
  • Ability to build relationships and influence stakeholders
  • Experience compiling technical documentation
  • Experience in a consultancy environment is an added bonus