Compliance & Quality Manager

£65,000 to £75,000
90% remote, with occasional travel to our London office and industry events. Travel expenses covered.

We build AI-driven IVD software that's classed as a medical device. It's a serious regulatory environment, and we need someone who can own the quality side of it properly.

Reporting to the VP of Compliance, you'll be the quality voice across the product development teams, and you'll deputise for the function when needed. The remit covers the QMS, design assurance, regulatory affairs, and the environmental and health and safety systems.

What you'll be doing

• Maintaining and improving the QMS against ISO 13485, ISO 9001, IVDR, UK MDR and FDA QSR. Running document control, CAPA, change control and the audit programme, and supporting audits from Notified Bodies, the MHRA, FDA and certification bodies.
• On the product side, you'll sit in cross-functional teams reviewing design requirements, V&V plans, test protocols and design transfer documentation, with software lifecycle work under IEC 62304.
• You'll also lead risk management under ISO 14971 using FMEA and FTA, cover software hazard analysis and cybersecurity risk, and handle the AI-specific work: traceability of training datasets and performance metrics, algorithm change control, model monitoring and retraining, and Good Machine Learning Practice.
• Plus supplier quality, post-market surveillance, complaint handling and operational quality alongside the Ops team.