Expert IVD Auditor - SaMD/Software Development

  • Posted: 24/05/2023
  • Salary: 70000
  • Location: Remote
  • Job Type: Permanent/Fixed Term
The opportunity to join a leading notified body within their in-vitro diagnostics (IVD) division. You will work collaboratively with international partners to align and streamline services in line with regulation with a focus on SaMD/ Software Development.

Candidate requirements:
  • Degree or advanced degree within life sciences sector.
  • 2+ years' experience working within QA/RA, QC.
  • 4+ years' experience working within software product development, manufacturing, testing or software production.
  • Working understanding of SaMD regulation inclusive of IEC 62304 and IEC 60601.
  • Experience and understanding of IVD's relating to software as a medical device and software development.
  • Understanding and dealing with regulatory requirements.
  • Review of quality management documentation and conducting audits on suppliers i.e. EU IVDR
  • Certified lead auditor or willing to undertake certification.
  • 50% travel expectation.
Hannah Hughes Team Lead/Senior Consultant

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