Senior QA/RA Consultant

United Kingdom,

Posted:35 days ago
Location:United Kingdom,
Job Ref:BH-33284-1
Job Type:Permanent
Salary:£55000 - £60000 per annum
Expiry date:12/6/2022
Contact:Libby Strachan
Contact Email:libby.strachan@xplorelifescience.com
Senior QARA Specialist – Medical Device
Xplore Life Science is recruiting for a Senior QARA Specialist. This role is ideal for someone who has a broad experience in regulatory affairs, specifically medical devices. We are looking for someone who is hands on and able to create most of the documents within the technical files.
Responsibilities
  • Undertaking US FDA 510(k)s, PMAs, IDEs, Pre-Submissions and Designations Submission
  • Support to maintain or expand market access to various markets including EU, USA, UKCA
  • Solving regulatory questions on classification, technical files, device master records
  • Conduct or advice on validation schemes
  • Quality Management Support
Requirements
  • Degree level education or relevant work experience
  • Experience within active medical devices (60601/62304)
  • Excellent communication, influencing and presentation skills
  • Strong knowledge of IVDR or MDR
Why should you apply now?
  • Remote working environment, with ability to travel to site
  • Exposure to a variety of devices, products and markets
  • The salary ranges between £55,000 - £60,000
  • Continuous career development
If you are a Senior RA Specialist, please apply now!

Apply now