Systems & Operations Manager

Cure Talent are delighted to be partnered with 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 problem they're solving is real and urgent. Their platform operates on the UK Class I medical device pathway, with a target market of 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 doing serious work. They use modern tooling, think carefully about process, and are building something that genuinely matters.

The Role

The business is coming to the end of its build phase. The founder has been carrying the compliance and operational burden alongside everything else, and it's time to hand that ownership to someone who can run with it.

This is a hands-on operational role. You will own, run and continuously improve the lean systems that keep around 500 processes aligned to a wide range of standards, frameworks and statutory obligations. You won't be making the judgement calls within each domain; those sit with named accountable leads across the business. What you will do is create and maintain the practical, proportionate infrastructure that allows the organisation to operate confidently and compliantly.

This is not a monitoring or audit role. The emphasis is firmly on operational management: making things work, keeping them sharp, and ensuring compliance is embedded into how the business runs day-to-day, not bolted on afterwards.

What You'll Be Responsible For

• Owning and optimising the SOPs, documentation and operational controls across a broad standards stack 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
• Running a lean control environment across approximately 500 processes, ensuring systems add value without creating unnecessary overhead
• Supporting readiness for UKCA declaration of conformity and ongoing UK MDR post-market surveillance obligations
• Coordinating cross-functional input from engineering, QA, regulatory, marketing and leadership through a structured weekly release cycle
• Using modern tooling (including no-code and AI-assisted systems) to keep operations efficient and scalable
• Helping scale safeguarding, HR and finance compliance as the business continues to grow

What We're Looking For

The right person has probably evolved into this kind of role over time. They'll have joined a small MedTech or SaMD business in a more defined function and, as the company grew, so did their remit. They ended up responsible not just for compliance, but for the systems, processes and operational structure that kept the business moving. That experience is what we're looking for here.

Essential:

• Operations or compliance management experience within a regulated environment, ideally medical device or healthcare technology
• Working knowledge of medical device and digital health standards; you don't need to be a specialist in every framework, but you need to know how to run systems that address them
• 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

Why This Role

This is a self-funded, well-resourced business targeting profitability within a couple of years, at which point US market expansion is the next step. If you want to be the person who builds the operational foundation of a mission-led business and grows with it, this is that opportunity.