Principal RA/QA Specialist – AI & SaMD

Doccla; London; Híbrido; GBP 70 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

25 days annual leave + up to 8 UK bank holidays

Flexible remote options

Employee stock options

Private health insurance

Free daily lunch at London HQ

Resumo da oferta

A leading healthtech company in London is seeking a Principal RA/QA Specialist with deep expertise in Software as a Medical Device regulations. The ideal candidate will navigate complex regulatory frameworks like the EU AI Act and drive quality initiatives for innovative medical solutions. This role offers competitive compensation, remote working options, and opportunities for professional growth within a diverse team committed to redefining healthcare delivery.

Qualificações

• Minimum 10 years of experience in Regulatory Affairs/Quality Assurance, preferably in the medical device industry with a focus on SaMD.
• Demonstrated expert-level knowledge and practical experience applying international standards including ISO 62304 and ISO 13485.
• Comprehensive understanding of EU AI Act, EU MDR, UK MDR, MHRA guidance on Software and AI as Medical Devices.

Responsabilidades

• Provide strategic leadership in Regulatory Affairs and Quality Assurance within a Software as a Medical Device (SaMD) environment.
• Drive the creation, approval, and continual enhancement of technical documentation for AI-based medical products.
• Act as a strategic liaison between Commercial, Technology, and Regulatory teams to align innovative initiatives.

Conhecimentos

Strategic RAQA mindset

Strong communication skills

Detail-oriented

Software tools skills (Confluence, Jira, GitHub)

Formação académica

Bachelor’s degree in Medical Engineering, Computer Science, Life Sciences, or a related field

Ferramentas

Confluence

Jira

GitHub

Descrição da oferta de emprego

Join to apply for the Principal RA/QA Specialist – AI & SaMD role at Doccla

Join to apply for the Principal RA/QA Specialist – AI & SaMD role at Doccla

Overview

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 Principal RA/QA Specialist

We are seeking a highly experienced and strategically minded RA/QA Senior Specialist with deep expertise in Software as a Medical Device (SaMD) and artificial intelligence (AI) regulatory frameworks, including the EU AI Act, ISO/IEC DIS 42001 (AI Management System), ISO/IEC 23894 (AI Risk Management), BS 30440:2023 (Validation framework for AI in healthcare), and MHRA guidance on Software and AI as Medical Devices. The ideal candidate will take a leadership role in navigating complex regulatory landscapes, ensuring compliance with international standards, and driving strategic quality initiatives to support the development and successful deployment of innovative driven medical solutions.

Regulatory Affairs and Compliance

• Provide strategic leadership in Regulatory Affairs and Quality Assurance (RAQA) within a Software as a Medical Device (SaMD) environment, ensuring alignment with evolving global standards and supporting innovation in regulated software development.
• Provide strategic oversight for interpreting and implementing regulatory frameworks such as the EU AI Act, ISO/IEC DIS 42001, ISO/IEC 23894, BS 30440:2023, ensuring comprehensive alignment with ethical, technical, and compliance considerations specific to AI and LLM applications in SaMD.
• Drive the creation, approval, and continual enhancement of in-depth technical documentation, including advanced risk assessments, robust regulatory strategies, and sophisticated post-market surveillance plans tailored for AI-based medical products.
• Proactively monitor global regulatory developments, ensuring the company remains at the forefront of emerging regulatory trends and translating complex regulations into clear, strategic actions for cross-functional teams.

Software Development Lifecycle

• Provide strategic leadership over the software development and release management process, ensuring comprehensive compliance with ISO 62304 and ISO 13485.
• Collaborate closely with engineering leadership to ensure that software modifications and updates adhere rigorously to regulatory and quality expectations before approval and deployment.
• Lead and refine advanced software validation and verification processes to guarantee product performance, regulatory compliance, and quality assurance standards.

Cross-Functional Collaboration

• Act as a strategic liaison between Commercial, Technology, and Regulatory teams to align innovative initiatives with high-level regulatory and quality expectations.

What Experience You’ll Bring to the Team

• Bachelor’s degree in Medical Engineering, Computer Science, Life Sciences, or a related field.
• Minimum 10 years of experience in Regulatory Affairs/Quality Assurance, preferably in the medical device industry with a focus on SaMD.
• Demonstrated expert-level knowledge and practical experience applying international standards including ISO 62304, ISO 13485, ISO 14971, ISO/IEC DIS 42001, ISO/IEC 23894, and BS 30440:2023.
• Comprehensive understanding of EU AI Act, EU MDR, UK MDR, MHRA guidance on Software and AI as Medical Devices, and related global regulatory frameworks specific to software-based medical technologies.

• Experience with software tools like Confluence, Jira, and Github.

What We’re Looking For

• Strategic RAQA mindset with strong communication and stakeholder skills; adept at translating regulatory requirements into clear direction for business and technical leaders.
• Detail-oriented with a strong grasp of big-picture thinking and step-change opportunities.
• Comfortable engaging across all organizational levels.
• Thrives in fast-paced, high-growth environments.
• Applies a flexible, systematic, and risk-based approach.
• Self-driven and highly engaged.

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, and Stockholm. 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 roles are fully remote, depending on the team and responsibilities.

What You’ll Get

• Annual Leave & Holidays – 25 days annual leave + up to 8 UK bank holidays
• Option to buy or sell holidays
• Remote Working – Flexible remote options
• £200 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*; 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. If the role involves access to children or vulnerable adults, a Disclosure and Barring Service (DBS) check will be required.

It is an offence to apply for such work if you are barred from working with children or vulnerable adults.

Seniority level

• Not Applicable

Employment type

• Other

Job function

• Education and Training

Industries

• Hospitals and Health Care

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