RA/QA Specialist

🌍 A Bit About Us We’re Doccla , 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 including UK, Ireland, France, and the DACH region to reduce hospital pressure, improve outcomes, and create a more resilient model of care. 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. 🚀 Why Join Us? This is your chance to join Doccla at a key stage in our growth . We’re building the category leader in Virtual Care and Remote Patient Monitoring. You’ll be part of a highly entrepreneurial, mission-driven team that combines expertise across clinical, technical, commercial, and operational domains. We’re solving real problems for patients and health systems and growing fast. 🧑‍⚕️ What You’ll Do as a RAQA Specialist This role provides for an RAQA Specialist supporting software quality, validation, and notified body remediation activities. The position is required to maintain delivery continuity during an active Technical Documentation review cycle and ongoing remediation of nonconformities (NCs). Without this backfill, critical regulatory and validation activities would be delayed, materially increasing certification and compliance risk. ✅ What Experience You’ll Bring to the Team Technical and Product Nonconformity Management (Approx. 60%) ● Own follow-up and closure of technical and product-related nonconformities raised by the notified body. ● Draft and maintain NC responses and objective evidence relating to software lifecycle, validation, and risk management documentation. ● Coordinate with Engineering and RAQA to ensure corrective actions are implemented and review-cycle ready. ● Support CAPA activities and internal audit follow-ups where software or product- quality root causes are identified. Software Validation Planning and Oversight (Core Responsibility) ● Own preparation, maintenance, and update of software validation plans in line with IEC 62304, ISO 13485, and internal QMS requirements. ● Ensure validation scope aligns with intended use, risk classification, and release strategy. ● Review validation protocols and reports to ensure completeness, traceability, and regulatory defensibility. Software Lifecycle and Risk Management Compliance ● Review software requirements, traceability matrices, and lifecycle documentation in accordance with IEC 62304. ● Support maintenance of the risk management file in line with ISO 14971, ensuring linkage to validation and Technical Documentation. 💡 What We’re Looking For 3–6 years’ experience in Medical Device / SaMD QA or RAQA Engineering. Must-Have Standards & Technical Experience ISO 14971: Expert knowledge in Risk Management application. IEC 62304: Comprehensive understanding of Software Lifecycle processes. (Good to have not a must) EU MDR Technical Documentation: Proven experience in preparing and maintaining documentation for regulatory compliance. 🧠 How We Work We empower everyone at Doccla 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, where you’ll find great lunch, barista coffee, and a pet-friendly space. Some roles are fully remote , depending on the team and responsibilities. 🎁 What You’ll Get Annual Leave & Holidays 🌴 25 days annual leave + up to 8 UK bank holidays 🔄 Option to buy or sell holidays Remote Working 🏡 Flexible remote options Financial Benefits 📈 Employee stock options 💸 4% pension on full basic pay 🛡️ 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 (London HQ) 🍝 Free daily lunch 🐶 Pet-friendly office Other Benefits 📚 £500 L&D budget per person 🚲 Cycle to work scheme Via Smart Health: 🧑‍⚕️ 24/7 GP appointments 🧠 Mental health support 🥗 Nutrition & fitness advice 🧪 Second opinions & health checks 🏆 In Return for Your Hard Work A competitive compensation package (base + stock options), with half-year and annual performance reviews The chance to work on patient-first, system-level healthcare challenges in one of Europe’s leading healthtech companies Opportunities for growth and leadership we want you to challenge the status quo, own your impact, and continue developing, with our full support 🤝 Diversity at Doccla We embrace diversity. To build a great product, we need a team with a wide range of perspectives, backgrounds, and experiences. We’re committed to equal opportunity hiring regardless of race, religion, gender identity, sexual orientation, age, disability, or background. If you're excited about the role, we encourage you to apply even if your experience doesn't match every point. 🔐 Safer Recruitment We are committed to safer recruitment practices. As Doccla is a CQC registered company, a Disclosure and Barring Service (DBS) check will be required for all roles. It is an offence to apply for such work if you are barred from working with children or vulnerable adults.