Medical Devices Compliance Lead (SaMD)

ACCURX IS SOLVING HEALTHCARE PRODUCTIVITY FOR THE NHS For decades, the NHS has struggled with fragmented systems that make simple tasks feel impossible. At Accurx, we’re changing that by building a single, system-wide platform that helps every patient get gold-standard, efficient, and joined-up care. What started as a way for GPs to text a patient, has now evolved into an all-in-one digital toolkit used by 98% of GP practices and 68% (and growing!) of NHS Trusts. Our platform now powers Total Triage https://www.accurx.com/primary-care to manage patient demand, and Self-Book https://www.accurx.com/booking that lets patients schedule their own appointments in seconds. We’ve automated routine care with Patient Questionnaires https://www.accurx.com/questionnaires for long-term conditions, while Accumail https://www.accurx.com/accumail finally allows staff-to-staff communication to happen instantly across different care settings. We’re now pushing the boundaries of the consultation itself with Accurx Scribe https://www.accurx.com/scribe, our AI-powered note-taker that drafts medical notes in real-time. We’re not just shipping features. We’re giving clinicians their time back and ensuring every patient journey is as smooth as it should be. THE ROLE At Accurx, we're building a world where everyone involved in a patient's care can communicate with each other. Right now, our software is used by thousands of NHS organisations to help teams work together and support the care of >65million patients every year. With ambitious plans for the future and exciting product development on the horizon, we’re committed to building with the same care, rigour, and impact that define the rest of our work. That’s where you come in. We’re looking for an experienced Compliance Lead with experience of class I-III medical devices, software as a medical device (SaMD) and AI as a medical device (AIaMD) to help us navigate and implement the requirements of UK MDR, laying the right foundations for medical device status. This is a high-impact, cross-functional role at the intersection of product, clinical safety, legal, and compliance. CHALLENGES YOU’LL SOLVE... - Technical File Ownership & Submission: - Own the structure, development and maintenance of technical files (STED or equivalent) across products, ensuring they are coherent, complete and submission-ready - Lead preparation for Approved Body and MHRA submissions, including coordination of inputs, query management and gap resolution - Define and implement internal standards for technical documentation, establishing what “good” looks like for submission-ready files - Quality Management System Implementation: - Lead the design, implementation and continuous improvement of our Quality Management System (QMS), aligned to ISO 13485 (uplift from ISO 9001) - Establish and embed core QMS processes, including design controls, change control and CAPA, ensuring they are operationalised across teams - Work cross-functionally with Product, Engineering, Clinical, Security and Service Management to embed regulatory requirements into how we design and build - Regulatory Strategy and Implementation: - Translate UK MDR and EU MDR requirements into clear, practical guidance that supports rapid and compliant product development - Assess product changes for regulatory impact and define required updates to documentation and processes - Implement and maintain risk management processes in line with ISO 14971, embedding risk-based thinking into product development - Approved Body & Audit Readiness: - Support the coordination of Approved Body interactions, including submissions, audits and responses to queries, ensuring audit readiness at all times - Post-Market Surveillance & Continuous Improvement: - Establish and maintain post-market and lifecycle processes from a systems and documentation perspective, ensuring regulatory requirements are consistently met - Act as the bridge between regulatory requirements and operational deli