Systems & Operations Manager

UK-based role in Bristol with a requirement to be on-site two days per week.

About the role

This is a hands-on operational role focused on owning, running, and continuously improving the lean systems that keep around 500 processes aligned to a wide range of standards, frameworks, and statutory obligations. You will create and maintain the practical, proportionate infrastructure that allows the organisation to operate confidently and compliantly, embedding compliance into day-to-day operations rather than treating it as an afterthought.

Responsibilities

• Own and optimise SOPs, documentation, and operational controls across standards including ISO 13485, ISO 14971, IEC 62304, ISO 27001, ISO/IEC 42001, UK GDPR, DTAC, DCB0129, DSPT, Cyber Essentials, WCAG 2.1 AA, MHRA vigilance, B Corp, and safeguarding legislation.
• Run a lean control environment across approximately 500 processes, ensuring systems add value without creating unnecessary overhead.
• Support readiness for UKCA declaration of conformity and ongoing UK MDR post-market surveillance obligations.
• Coordinate cross-functional input from engineering, QA, regulatory, marketing, and leadership through a structured weekly release cycle.
• Use modern tooling (including no-code and AI-assisted systems) to keep operations efficient and scalable.
• Help scale safeguarding, HR, and finance compliance as the business grows.

Requirements

• Operations or compliance management experience within a regulated environment, ideally medical device or healthcare technology.
• Working knowledge of medical device and digital health standards; ability to run systems addressing them without needing to be a specialist in every framework.
• Ability to manage lean operations at scale without creating overhead.
• Tech-savvy and comfortable with modern tools including no-code platforms and AI-assisted workflows.
• Collaborative, calm, and pragmatic; able to work cross-functionally in a small, fast-moving team.
• UK-based and able to commit to two days per week in Bristol.

Nice to have

• Familiarity with agile software development in regulated environments.
• Background in clinical or regulatory affairs.
• Experience working with NHS or Local Authority markets.

About the company

A well-funded, mission-driven healthtech startup building a regulated digital support platform for families and children with suspected, waitlisted, or diagnosed autism and ADHD. With over one million people on NHS waiting lists, the company addresses a real and urgent problem. Their platform operates on the UK Class I medical device pathway, targeting NHS and Local Authorities. Founded by an engineer-turned-entrepreneur with a background in regulatory systems and a personal connection to the cause, this is a small, purposeful team using modern tooling to build something impactful.

Pay

£70,000 to £90,000 per year.