Doccla
RA/QA Specialist (SaMD)
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A Bit About Us
Weāre Doccla, and weāre 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 to reduce hospital pressure, improve outcomes, and create a more resilient model of care.
Weāre backed by top European investors, having secured Ā£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.
Weāre building the category leader in Virtual Care and Remote Patient Monitoring. Youāll be part of a highly entrepreneurial, mission-driven team that combines expertise across clinical, technical, commercial, and operational domains.
Weāre solving real problems for patients and health systems and growing fast.
What Youāll Do as a RA/QA Specialist
This role provides a RAQA Specialist for our Software as a Medical Device (SaMD) portfolio, based in the UK and supporting regulatory activities across the UK, EU, and international markets. The position is needed to maintain delivery continuity during an active notified body Technical Documentation and general QA support.
What Experience Youāll Bring to the Team
SaMD Technical Documentation (Core Responsibility)
- Prepare, maintain, and update Technical Documentation in line with EU MDR and UK MDR 2002.
- Maintain the GSPR checklist, current objective evidence from SDLC, cybersecurity, usability, and risk management outputs.
- Own labelling and IFU compliance for software, including UDI, eIFU, in-app labelling, and UKCA/CE marking requirements.
- Support software qualification and classification rationale and intended purpose statements.
- Support clinical evaluation for software.
- Assess software releases and design changes for regulatory impact, including significant change determination and notified body notification.
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Risk Management and Post-Market Surveillance
- Own and maintain the risk management file in line with ISO 14971 and ISO/TR 24971, including hazard analysis, risk controls, and benefit-risk determination for software.
- Support risk outputs are traceable to software requirements, verification, usability, and the Technical Documentation.
- Support PMS plan, PMS report / PSUR, and PMCF plan and evaluation report in line with EU MDR Articles 83 to 86 and Annex XIV Part B.
- Analyse complaints, incidents, trends, and real-world performance data, feeding outputs back into risk management and clinical evaluation.
- Support vigilance reporting to MHRA and EU competent authorities, including FSCAs and trend reporting.
- Act as a day-to-day point of contact for queries and commitments
- Coordinate with Engineering, Clinical, and Quality to ensure corrective actions are implemented and submission-ready.
UK and International Regulatory Strategy
- Support UKCA and CE marking, MHRA registrations
- Support international market access, including FDA (510(k)/De Novo) and other markets as the business expands.
- Monitor regulatory intelligence for SaMD and AI/ML (MHRA Software and AI as a Medical Device programme, MDCG guidance, FDA guidance, IMDRF) and assess impact on products and the QMS.
- Support CAPA and internal audit follow-ups where regulatory root causes are identified.
What Weāre Looking For
- 3 to 6 years' Regulatory Affairs experience in Medical Devices, with a focus on SaMD.
Must-Have
- EU MDR / UK MDR Technical Documentation for software: Proven experience preparing and maintaining it for notified body review.
- ISO 14971: Hands-on experience owning a risk management file for SaMD.
- SaMD qualification and classification: Practical application of MDCG 2019-11 / EU MDR Rule 11.
- IEC 62304, IEC 82304-1, and IEC 62366-1 experience.
Good to have
- Notified body interaction: Hands-on experience responding to NCs or review questions.
- FDA submissions experience for software devices preferable
- Experience with PMS plans, PSURs, and PMCF plans and reports.
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, youāll need a can-do attitude and an action-oriented approach, along with a willingness to learn and grow through open feedback.
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Weāre 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 1ā3 days per week, where youāll 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 Youāll 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
- Ā£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 Europeās 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.
Weāre 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.
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