RA/QA Specialist
SKILLS
FULL DESCRIPTION
RA/QA Specialist at [Employer hidden — view at passion-project.co.uk]
[Employer hidden] is redefining healthcare delivery with Virtual Ward and Remote Monitoring Solutions. We work with over 60% of NHS ICBs and are backed by top European investors. We are seeking a RA/QA Specialist to own risk management and technical documentation for our SaMD platform.
About [Employer hidden]
We’re [Employer hidden], and we’re redefining where and how healthcare is delivered. Our Virtual Ward and Remote Monitoring Solutions enable hospitals and health systems to care for patients at home. We support patients across the full care journey from early discharge and acute recovery to long-term condition management and proactive care. We provide everything clinicians need to deliver safe, effective Virtual Care: medical-grade devices, logistics, patient onboarding, EHR integration, and an end-to-end clinical platform built around real-world workflows. We currently work with over 60% of NHS ICBs and supporting health systems across the UK, Ireland, France, and the DACH region. We’re backed by top European investors, having secured £35m in Series B funding led by Lakestar, with participation from Elaia, General Catalyst, Speedinvest, and Bertelsmann.
What You’ll Do as a RA/QA Specialist
As our RA/QA Specialist, you are the vital link between Engineering and Compliance. You will own the risk management and technical documentation for the [Employer hidden] SaMD platform. This is an execution-focused role where you’ll ensure our product lifecycle is audit-ready, MDR-compliant, and built on a defensible risk framework.
Risk Management Ownership (60%)
- Maintain Standards: Lead ISO 14971-compliant risk files for all active product versions.
- Release Management: Drive risk updates for every release and patch.
- Ensure Traceability: Connect the dots between Hazards, Requirements, Risk Controls, and Verification evidence.
- Tooling Support: Help configure Jira for structured risk traceability.
- Feedback Loop: Align risk docs with clinical evaluations, field safety feedback, and PMS signals.
- Audit Support: Assist in closing Notified Body non-conformities related to risk.
Technical Documentation & Release Review (30%)
- Technical Integrity: Review and update Technical Documentation (TD) for every release cycle.
- Accuracy Check: Ensure consistency across the IFU, risk files, and intended purpose.
- Audit Prep: Support preparation for Notified Body audits and ongoing surveillance.
- Design Reviews: Participate in internal design reviews from a compliance perspective.
Cross-Functional Support (10%)
- Engineering Partnership: Work with developers to ensure risk controls are correctly implemented.
- Software Lifecycle: Provide input into documentation to ensure alignment with IEC 62304.
- Process Improvement: Help optimise our traceability systems and documentation tools.
What Experience You’ll Bring to the Team
- Experience: 3–6 years in Medical Device or SaMD within a QA or RAQA Engineering capacity.
- Must-Haves: Deep knowledge of ISO 14971 and EU MDR requirements.
- Mindset: A hands-on 'executor' who enjoys working at the intersection of technical engineering and regulatory standards.
How We Work
We empower everyone at [Employer hidden] to take ownership of their work and the company's mission. We act ethically and always put patient safety and outcomes first. To thrive here, you’ll need a can-do attitude and an action-oriented approach, along with a willingness to learn and grow through open feedback. We’re a hybrid team, with offices in London, Denmark, Germany, and Stockholm. Most of our team is London-based and enjoys in-person time at our WeWork HQ 1–3 days per week. Some roles are fully remote, depending on the team and responsibilities.
What You’ll Get
- Annual Leave: 25 days + up to 8 UK bank holidays, option to buy/sell holidays
- Remote Working: Flexible remote options
- Financial Benefits: Employee stock options, 4% pension, 4x salary life insurance
- Health & Wellness: Private health insurance, 4 months full pay for birthing parent, 4 weeks full pay for non-birthing parent, sick pay
- In-Office Perks: Free daily lunch, pet-friendly office
- Other: £500 L&D budget, cycle to work scheme, Smart Health benefits
Diversity & Safer Recruitment
[Employer hidden] embraces diversity and is committed to equal opportunity. A Disclosure and Barring Service (DBS) check will be required. It is an offence to apply if barred from working with children or vulnerable adults.