RA/QA Lead

🌍 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 RA/QA Lead The Senior RAQA Lead is a senior individual contributor and operational lead within the Regulatory Affairs and Quality Assurance function. Reporting to the Head of Regulatory and Compliance, this role owns day-to-day quality assurance across the software development lifecycle and provides regulatory expertise to support active EU MDR conformity assessment, post-market obligations, and cross- functional product quality processes. This role is suited to a quality and regulatory professional with deep SaMD and software lifecycle experience who can operate independently, manage complex workstreams, and embed quality practices directly within engineering and product development processes. ✅ What Experience You’ll Bring to the Team Software Quality Assurance • Own and maintain quality processes across the software development lifecycle in accordance with IEC 62304, including software classification, unit decomposition, and verification and validation activities. • Embed quality gates within engineering workflows, ensuring change control, software release, and defect management processes meet regulatory requirements. • Lead software problem resolution and non-conformance processes, including root cause analysis and CAPA management. • Define and maintain software quality metrics, traceability matrices, and test documentation to support Technical Documentation and audit readiness. • Collaborate with engineering leads to maintain the software development and maintenance plan and ensure IEC 62304 artefacts are complete and current. Quality Management System • Own and maintain the QMS, ensuring continued compliance with ISO 13485 and EU MDR requirements. • Lead the internal audit programme with a focus on software and product quality processes. • Prepare for and support external audits, including Notified Body surveillance audits. • Maintain document control processes and ensure version integrity across the quality system. Regulatory Affairs • Support maintenance and continuous improvement of the EU MDR Technical Documentation, including software documentation, intended purpose, risk management, and clinical evaluation. • Monitor and assess regulatory intelligence across EU MDR and applicable international frameworks, communicating impact to the Head of Regulatory and Compliance. • Coordinate with Notified Body contacts and the EU Authorised Representative on conformity assessment activities. • Support post-market surveillance and vigilance activities, including PMCF planning and PSUR preparation. Risk Management • Maintain the risk management file in accordance with ISO 14971, with particular focus on software-related hazards and use error scenarios. • Conduct and document risk assessments for product changes, software updates, new features, and new indications. • Integrate risk outputs with clinical evaluation, software lifecycle documentation, and post-market processes. Cross-functional Collaboration • Act as the primary RAQA contact for product and engineering teams, providing regulatory and quality input at design review, sprint, and release stages. • Support clinical evidence activities, including real-world evidence study design and CER/CEP documentation. • Contribute regulatory perspective to AI and algorithm governance, including EU AI Act obligations where applicable. Team and Operations • Provide operational oversight of RAQA workstreams and contribute to team planning and prioritisation. • Mentor and support junior RAQA team members where applicable. • Drive RAQA process improvement, tooling, and automation initiatives. 💡 What We’re Looking For Essential • Significant experience in quality assurance or regulatory affairs within the medical device or digital health industry (minimum 5 years). • Demonstrable expertise in IEC 62304 software lifecycle processes for medical device software. • Strong working knowledge of EU MDR (2017/745) and ISO 13485. • Experience with SaMD products, ideally in a cloud-hosted or platform context. • Proven ability to work directly with engineering and product teams to embed quality practices. • Familiarity with Technical Documentation requirements, including software documentation, clinical evaluation, and risk management files. • Excellent written communication skills, with the ability to produce precise regulatory and quality documentation. Desirable • Knowledge of ISO 14971 and usability engineering (IEC 62366). • Exposure to post-market surveillance, vigilance, and PMCF activities. • Familiarity with EU AI Act obligations relevant to software as a medical device. • Experience working with Notified Bodies or Authorised Representatives. • Background in virtual care, remote monitoring, or digital therapeutics. • Experience with cybersecurity standards relevant to connected medical devices (e.g. IEC 81001-5-1). 🧠 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. 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 of our teams are fully remote, depending on the team and responsibilities. This includes our Engineering, Clinical & Patient Support teams. 🎁 What You’ll Get Annual Leave & Holidays 🌴 25 days annual leave + up to 8 UK bank holidays [this varies depending on the role] 🔄 Option to buy or sell holidays Remote Working 🏡 Flexible remote options 💻 Remote working stipend 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* 👶🏽 Phased return back to paid work 🤒 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.