About the opportunity

This is a fully remote role with flexible working, designed to support a healthy work-life balance. You will collaborate with a small, highly skilled team and meet in person for a team event at least quarterly (all expenses covered).

In this role, you will

• Deliver quality and regulatory client projects focused on medical devices with software elements
• Educate clients on why regulatory documentation is needed, not just what is required
• Create, review, and structure medical device technical documentation
• Support quality and design activities aligned to medical device regulations and standards
• Help clients compile and organise documentation into regulator-ready formats
• Adapt internal templates to meet specific client and product needs
• Lead and contribute to client meetings, guiding discussions with clarity and confidence
• Liaise closely with software engineers, product teams, HR, and senior stakeholders
• Work collaboratively with colleagues to deliver joined-up, practical solutions
• Manage and deliver multiple client projects simultaneously in a consulting environment

Essential experience

• Background in software-based medical devices
• Experience working within medical device quality management environments
• Experience working closely with engineers, supporting, guiding, and helping shape documentation at the shoulder of development teams
• Strong understanding of quality and regulatory expectations for medical devices
• Confident communicator, able to engage with stakeholders from highly technical engineers to senior leadership
• Highly organised, methodical, and detail-driven
• Comfortable working independently while contributing to a collaborative team

Desirable experience

• Medical device technical documentation
• ISO 13485 or other medical device standards
• Gap analysis or internal auditing
• Review of complex technical documentation
• Process and procedure development
• Exposure to AI or advanced software within medical devices
• Client-facing consultancy experience

Why you will love working here

• Salary between £45,000 and £55,000, depending on experience
• 28 days annual leave, including bank holidays plus your birthday off
• Fully remote working with quarterly in-person team events (expenses covered)
• Vitality Healthcare
• Life Assurance (4x salary)
• Training & Development: Ongoing professional development and support for further certifications
• A values-driven consultancy where quality, integrity, and collaboration are genuinely lived, not just written on a website
• Progression opportunities as the medical device and international standards offering continue to grow