RAQA Specialist (SaMD)

Were Doccla and were 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.

Were backed by top European investors having secured 35m in Series B funding led by Lakestar with participation from Elaia General Catalyst Speedinvest and Bertelsmann.

This is your chance to join Doccla at a key stage in our growth.

Were building the category leader in Virtual Care and Remote Patient Monitoring. Youll be part of a highly entrepreneurial mission-driven team that combines expertise across clinical technical commercial and operational domains.

Were 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.

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.

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.

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.

• 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.

We empower everyone at Doccla to take ownership of their work and the companys mission. We act ethically and always put patient safety and outcomes first.

To thrive here youll need a can-do attitude and an action-oriented approach along with a willingness to learn and grow through open feedback.

Were 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 13 days per week where youll 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.

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

• 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 Europes 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

We embrace diversity. To build a great product we need a team with a wide range of perspectives backgrounds and experiences.

Were committed to equal opportunity hiring regardless of race religion gender identity sexual orientation age disability or background. If youre excited about the role we encourage you to apply even if your experience doesnt match every point.

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.