Compliance and Regulatory Manager - Digital Health; SaMD

Role details: This is a full time role for 40 contracted hours per week

Salary: £52,000 - £68,000

Location: We are a hybrid team, based throughout the UK. We offer the flexibility to work outside of the UK up to 90 days per year, however you must be able to work and live permanently within the UK, and travel to London at least 4 times a year for team meeting sessions and additionally as needed.

Isla Health is a venture-backed health-tech startup, supporting our partners across the UK, EU and internationally. We’ve built a new category of healthcare technology which we refer to as the Digital Pathway Platform (DPP). Founded in 2019, we now support 25% of NHS Trusts and see 2 million submissions on the platform every year.

As a company, we’re all laser focused on enabling a scalable model of care which empowers healthcare staff and improves patient outcomes. The DPP supports this by setting up digital pathways which are remote-first and asynchronous. As pathways harness sophisticated automation, clinical algorithms and intelligent cohorting, patients always take the optimised route through their pathway, thereby delivering a step change in clinical productivity.

We're looking for a Compliance Manager to take ownership of quality, regulatory and business compliance across Isla Health.

As our platform scales, we expand internationally and our technology supports increasingly sophisticated clinical pathways, our regulatory and compliance obligations are becoming more complex. We need someone who can ensure we're meeting those obligations, managing risks proactively and embedding the right standards across the business.

You'll oversee our Quality Management System (QMS), drive our medical device regulatory readiness, and manage a broad range of compliance activities spanning information governance, data protection, IT security and wider business operations.

A big part of this role is ensuring that our processes and controls aren't just documented, but are consistently understood and followed. You'll work closely with teams across Isla to identify gaps, improve how we operate and make sure everyone understands their responsibilities when it comes to quality, security and compliance.

This is a highly hands-on role with significant ownership. You'll work alongside our Engineering, Product, Delivery and Operations teams, as well as external regulatory and clinical specialists, to translate complex requirements into practical, scalable processes.

We're looking for someone who is highly organised, detail-oriented and proactive. Someone who enjoys getting into the detail, but can also step back, challenge how things are done and drive improvements across the business. You'll play an important role in ensuring Isla can continue to grow quickly while maintaining the high standards of quality, safety and security our customers rely on.

• Own our Quality Management System:
  Act as our Quality Management Officer (QMO), ensuring our QMS is effective, up to date and embedded across Isla. Lead internal audits, CAPAs, non-conformances, change control, supplier monitoring and management reviews, ensuring issues are resolved, actions are completed and improvements are sustained.
• Drive medical device regulatory compliance:
  Take ownership of our medical device regulatory roadmap, working with external specialists and internal teams to progress our Class IIa ambitions, including classification, registration, ISO 13485 readiness, technical documentation and post-market surveillance. Ensure requirements are understood, work is prioritised and progress is driven through to completion.
• Coordinate clinical safety compliance: Work closely with our Clinical Safety Officer, Product and Engineering…