Medical Devices Compliance Lead (SaMD)

The Role

At [Employer hidden], 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 delivery, enabling teams to move quickly while remaining compliant
  • Monitor developments across UK MDR, EU MDR and relevant standards, translating changes into practical updates to processes and documentation

What’s in it for me?

You'll be joining an established but fast-growing Tech for Good movement, where we're led by our Principles and our mission to fix healthcare communication.

• Benefits to suit you: adjust your healthcare cover, your pension or life insurance, whatever stage you’re at in life
• Flexible working: We are an office first culture and ask that you’re in our (dog-friendly) Shoreditch office 3 days a week, with core hours of 10am - 4pm
• Time off: You’ll get 28 days of holiday (plus bank holidays) and up to 4 weeks to work from anywhere per year
• Family matters: We offer enhanced parental leave, fertility support and parental loss support
• We have our very own Chef! Free healthy breakfasts, snacks and lunches will be provided, with the occasional sweet treat!

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