RA​/QA Specialist; SaMD

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  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, Speed invest, and Bertelsmann.

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.

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.

• 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.

• 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.

• 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.