Principal RA/QA Specialist - AI & SaMD

A Bit About Us

We're Doccla, the virtual ward company. We provide patients and clinicians with the transformative power of remote patient monitoring.

Our existing customers are Hospitals, Community Services, and NHS Commissioners that we partner with to deliver tech enabled virtual wards. With our technology, logistics, and support patients can be discharged from a hospital ward to a virtual one and recover in the comfort of their own homes. Patients love our care pathways and health services become more efficient; it's a win-win.

Doccla is a growing health tech startup; we have secured a £35ml at Series B, led by European VC Lakestar, with new investors French VC Elaia and existing investors General Catalyst, Speedinvest and the investment leg of German media company Bertelsmann also participating. We're solving real problems for patients and health systems and we are growing at exceptional speed. We're looking for dedicated people with a passion for solving the problems in healthcare.

This is your chance to join us at a key stage of our growth. Our ambition is to be a category leader for virtual healthcare. You will be joining a highly entrepreneurial team that combines technical, clinical, operational, and commercial colleagues.

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.

Qualifications and Experience:

• 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.

Personal Skills:

• 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 to take ownership and responsibility for the company and their role within it. We act ethically and think of helping patients and protecting their safety first.

Whatever your role is, to thrive at Doccla, a can-do and action oriented attitude is essential. As is being a clear and open communicator who is receptive to feedback.

Our team is hybrid with offices in London, Denmark, Germany & Stockholm. Most of the team lives in and around London and visits the office one to three times per week to enjoy in person meetings, free lunch with the team, and the general perks of a WeWork with a glorious barista. The extent of remote vs office working will depend on your role, as some roles have the flexibility to be fully remote.

We have an employee equity pool that you can be part of so that as the company continues to grow you'll have a share in its success.

Some of our employee benefits include

• Annual Leave & Holidays:
  • 🌴 25 days of annual leave plus up to 8 bank holidays per year.
  • 🔄 Flexibility to buy or sell holidays back to the company.
• Remote Working:
  • 🏡 Flexible Remote Work: Options to work remotely, giving you the freedom to balance work and life.
  • 💻 Home Office Setup: £200 remote working stipend to enhance your home office.
• Financial Benefits:
  • 📈 Employee stock options.
  • 💸 4% pension on full basic pay.
  • 🛡️ 4x basic pay for Life insurance.
• Health & Wellness:
  • 🩺 Private health insurance.
  • 🫄 4 months full pay for the birthing person.*
  • 👶🏽 4 weeks full pay for the non-birthing person.*
  • 🩺 Sick pay
• Workplace Perks (if not remote):
  • 🍝 Daily lunch provided at HQ.
  • 🐶 Pet-friendly office
• Other benefits include:
• 📚 £500 Learning & Development budget per employee.
• 🚲 Cycle to work scheme.
• via Smart Health:
• 24/7 online GP appointments
• Mental health support
• Nutrition advice
• Fitness plans
• Second medical opinions
• Health checks
  

What do you get for all your hard work?

• A competitive compensation package (base + options) with half year and annual performance reviews.
• Work at one of the most patient focussed and client centric healthtech startups, backed by top VC firms, Lakestar, Elaia, General Catalyst & Speedinvest.
• Growth. We want you to keep growing. That means trying new things, leading others, challenging the status quo and owning your impact. Always with our complete support.

Diversity at Doccla
We embrace diversity at Doccla. To build a product that is valued we need a team with all kinds of different perspectives, experiences and backgrounds. That's why we're committed to hiring people from different backgrounds, race, religion, national origin, gender identity, sexual orientation, gender identity, age or disability.

We understand that applying for a new job takes a lot of work and we really value your time. We are really looking forward to reading your application!

Safer Recruitment

Doccla is committed to the principles of safer recruitment, ensuring that safeguarding and promoting the welfare of children and vulnerable adults is central to our recruitment processes.

A Disclosure and Barring Service (DBS) check will be required for all posts with access to children or vulnerable adults. Please note that it is an offence to apply, offer or accept to do any work with children (paid or unpaid) if disqualified from working with children.