Description
Quality Assurance & Regulatory Affairs Lead – Digital Health / SaMD
London, UK
We’re supporting a fast-growing AI-led digital health company hiring its first dedicated QA/RA Lead. You’ll be the sole QARA contact, owning the selection and implementation of a fit-for-purpose QMS and helping shape SaMD regulatory strategy as the company scales.
The Role
- Identify, configure, and implement a scalable QMS tailored to SaMD, aligned with ISO 13485, ISO 14971, IEC 62304, and 21 CFR Part 820.
- Run core QMS processes day to day (document control, change control, CAPA, internal audits).
- Support regulatory strategy and submissions for key markets (UK, EU, US) and interact with regulators / notified bodies as needed.
- Ensure audit readiness and support external inspections and certifications.
- Train and guide engineering, clinical, and commercial teams on QA/RA requirements and best practice.
- Act as the internal authority for QA/RA, highlighting risks, mitigations, and compliance impacts.
Requirements
Must-haves:
- QA and/or RA experience in medical devices, diagnostics, or digital health.
- Hands-on work within a QMS in a regulated setting.
- Solid knowledge of ISO 13485, ISO 14971, IEC 62304, and SaMD expectations.
- Experience supporting audits or inspections.
- Comfortable being the sole QA/RA Lead and making clear, pragmatic decisions.
Nice-to-haves:
- Exposure to SaMD pathways (MDR, UKCA, FDA).
- Startup / scale-up experience.
- Experience with multi-region regulatory strategies.
- Familiarity with cybersecurity, privacy, and clinical evaluation for digital health.
If you want genuine ownership of QA/RA, to implement a QMS that fits a modern SaMD business, and to grow with a high-potential health tech company, this is the right move.