Systems & Operations Manager

Cure Talent are 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. Their platform operates on the UK Class I medical device pathway, targeting NHS and Local Authorities.

About the role

The business is transitioning from build phase to operational maturity. The founder has been managing compliance and operations; this role takes ownership of those systems. You will run and continuously improve the lean infrastructure that keeps ~500 processes aligned to a wide range of standards, frameworks, and statutory obligations. The focus is on operational management—making systems work efficiently and embedding compliance into daily operations.

Responsibilities

• Own and optimize 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.
• Maintain a lean control environment for ~500 processes, ensuring systems add value without unnecessary overhead.
• Support 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 (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 in a regulated environment, ideally medical device or healthcare technology.
• Working knowledge of medical device and digital health standards; ability to manage systems addressing them without deep specialization.
• Ability to manage lean operations at scale without creating overhead.
• Comfort with modern tools, including no-code platforms and AI-assisted workflows.
• Collaborative, calm, and pragmatic; able to work cross-functionally in a 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 few years, with US market expansion as the next step. You’ll build the operational foundation of a mission-led company and grow with it.

Pay

£70,000 to £90,000