ISO 13485 QMS Implementation Consultant
- Apr 23
- 1 min read
ISO 13485 QMS Implementation Consultant — IVD Diagnostics Startup | UK | Freelance/Contract
We are an early-stage UK diagnostics startup developing lab-based IVD assays. We are building our quality management system from the ground up and need a hands-on consultant — someone who writes procedures, not just advises on them.
What you will do:
• Design and build a complete ISO 13485:2016 QMS from scratch for a lab-based IVD environment
• Write SOPs, work instructions, forms and templates — design control, document control, CAPA, risk management, supplier qualification, and more
• Develop IVD-specific procedures: analytical validation, reagent/material control, instrument qualification
• Establish document control and change management processes
• Prepare documentation and the team for first notified body / MHRA audit readiness
• Support UKCA/CE marking strategy and UKIVDR compliance planning
What we are looking for:
✅ Proven ISO 13485 QMS builds from scratch — with examples
✅ Direct IVD or diagnostics industry experience
✅ Strong technical writing — clear, audit-ready procedures
✅ UK regulatory knowledge — MHRA, UKIVDR, UKCA
➕ Experience with pre-revenue or early-stage startups
➕ Familiarity with lab-based analytical validation
Engagement: Flexible — fractional, fixed-term, or project-based. This is a hands-on role; we need someone who will build and write, not just advise.
To apply: Send your CV or LinkedIn profile, a brief overview of QMS builds you have led, and examples of SOPs or procedures you have written. We will respond within a few working days.
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