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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:
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