Remote RA/QA Engineer - SaMD Risk & Compliance

Doccla; Greater London; Hybrid; GBP 65,000 - 85,000; Full time

Benefits offered by this job

25 days annual leave + up to 8 UK bank holidays

Option to buy or sell holidays

Flexible remote options

Employee stock options

4% pension on full pay

Private health insurance

Free daily lunch at London HQ

£500 L&D budget per person

Job summary

A healthcare technology company based in London is seeking a RA/QA Engineer to manage risk and ensure compliance in their innovative SaMD platform. The ideal candidate will have 3–6 years of experience in Medical Device QA, a strong understanding of ISO 14971 and IEC 62304 regulations, and demonstrated capabilities in traceability management. This hybrid role offers flexibility with in-office options, extensive health benefits, and opportunities for growth in a mission-driven environment focused on patient care.

Qualifications

• 3–6 years’ experience in Medical Device / SaMD QA or RAQA Engineering.
• Strong working knowledge of ISO 14971, IEC 62304, and EU MDR requirements.
• Experience in release-based software environments.

Responsibilities

• Own and execute Risk Management and Technical Documentation tasks.
• Ensure audit-ready risk framework embedded in product lifecycle.
• Maintain traceability between requirements, verification & validation, and risk controls.

Skills

Medical Device / SaMD QA experience

ISO 14971 knowledge

IEC 62304 knowledge

Traceability management

Interaction with Notified Bodies

Systems-thinking mindset

Job description

A healthcare technology company based in London is seeking a RA/QA Engineer to manage risk and ensure compliance in their innovative SaMD platform. The ideal candidate will have 3–6 years of experience in Medical Device QA, a strong understanding of ISO 14971 and IEC 62304 regulations, and demonstrated capabilities in traceability management. This hybrid role offers flexibility with in-office options, extensive health benefits, and opportunities for growth in a mission-driven environment focused on patient care.