QA/RA IVD Consultant

Remote work, England

Posted:17 days ago
Location:Remote work, England
Job Ref:BH-33724
Job Type:Permanent
Salary:£35000 - £55000 per annum
Expiry date:12/6/2022
Contact:Libby Strachan
Contact Email:libby.strachan@xplorelifescience.com
QARA IVDR Consultant

Xplore Life Science is recruiting for a QARA Consultant. This role is ideal for someone who has a broad experience in regulatory affairs, specifically IVDs. We are looking for someone who is hands on and able to create 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
  • Excellent communication, influencing and presentation skills
  • Good knowledge of IVDR
  • Experience within FDF 510(k)s
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 £35,000 - £55,000
  • Continuous career development
If you specialise within IVD, please apply now!

Apply now