Open role · Quality · Regulatory · Product
Quality & Regulatory Intelligence Specialist
Help make sure QMSROOT understands Quality work the way experienced practitioners do.
You will work between domain expertise and product — challenging assumptions, testing workflows and helping translate Quality and regulatory requirements into defensible product behaviour.
What you’ll work on
- Review product workflows for Quality and regulatory accuracy.
- Challenge intelligence outputs, assumptions and evidence handling.
- Help define realistic CAPA, PMS, audit, documentation and QMS use cases.
- Test whether product results would stand up in real Quality work.
- Contribute to product language, examples and acceptance criteria.
What we’re looking for
- Practical experience in regulated Quality, Regulatory Affairs or QMS.
- Strong understanding of evidence and at least one relevant Quality process such as CAPA, complaints/PMS, audits, document control or regulatory compliance.
- Comfortable questioning both software and domain assumptions.
- Able to explain complex requirements clearly.
- Interested in how intelligence can support — not replace — human Quality decisions.
Medical-device experience is valuable, but QMSROOT is not limited to one regulated industry.
Before you apply
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