QA/RA Consultant

Glasgow, Glasgow City, Scotland, Scotland

Posted:21 days ago
Location:Glasgow, Glasgow City, Scotland, Scotland
Job Ref:BH-33285
Job Type:Permanent
Salary:£30,000 - £45,000
Expiry date:12/6/2022
Contact:Libby Strachan
QARA Consultant – Medical Device
Xplore Life Science is recruiting for a QARA Consultant. 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 documents within the technical files.
  • 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
  • Degree level education or relevant work experience
  • Excellent communication, influencing and presentation skills
  • Good knowledge of IVDR or MDR
  • Experience within active medical devices (60601/62304) – Not essential
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 £30,000 - £45,000
  • Continuous career development
If you are a RA Specialist, please apply now!

Apply now