Systems & Operations Manager

About 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.

Responsibilities

• 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
• Cooking 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

Requirements

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.

Qualifications

• 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
• 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

Skills

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

Benefits

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

Pay

£70,000 to £90,000

Schedule

Flexible, but two days per week in Bristol