RA/QA Specialist (SaMD)

Doccla UK Limited; Greater London; Hybride; GBP 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

Private health insurance

Stock options

Remote working stipend

Hybrid work model

Résumé du poste

Doccla UK Limited is hiring a Regulatory Affairs Specialist for its SaMD portfolio. You will manage EU/UK MDR technical documentation, risk management, and labeling compliance, ensuring regulatory readiness across markets. The role supports changes, PMS, and vigilance activities.

You will work in a hybrid model with London presence, collaborating with Engineering, Clinical and Quality teams to maintain compliance and timely submissions.

Qualifications

• EU MDR / UK MDR Technical Documentation experience
• Hands-on risk management ownership (SaMD)
• Practical MDCG 2019-11 / EU MDR Rule 11
• Experience with IEC 62304, IEC 82304-1, IEC 62366-1

Responsabilités

• Prepare and maintain Technical Documentation for EU/UK MDR
• Maintain GSPR checklist and evidence from SDLC, cybersecurity, usability, risk management
• Own labelling and IFU compliance for software (UDI, eIFU, in-app labels)
• Support software qualification and classification rationale
• Assist clinical evaluation for software
• Assess regulatory impact of releases and changes
• Coordinate with Engineering, Clinical, and Quality for CAPA
• Support UKCA, CE marking and MHRA registrations

Connaissances

Regulatory Affairs

SaMD

EU MDR / UK MDR

ISO 14971

IEC 62304

MDCG guidance

FDA submissions

Risk management

Description du poste

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 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 You’ll 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.

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 We’re 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, 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.