Job Description
About the Company
We re working with a fast-growing, venture-backed technology company operating within the healthcare space.
Their product is already being used in live environments with large enterprise customers, delivering measurable improvements in efficiency and allowing end users to focus more on high-value tasks. Following recent funding, the company is now entering a key growth phase as they scale their product and expand adoption.
The Role
This is a high-impact position responsible for owning and shaping how compliance operates across the business. Sitting at the intersection of product, engineering, and operations, you will ensure regulatory requirements are met while enabling the company to move quickly and scale effectively.
You will take full ownership of the Quality Management System (QMS), oversee medical device compliance, and act as the internal lead for ISO standards. This role combines strategic oversight with hands-on execution and will be critical in building scalable, audit-ready processes.
There is also a clear pathway to take on (or grow into) a Clinical Safety Officer (CSO) position, contributing to clinical risk management and safety governance as the product evolves.
Key Responsibilities
- Own and evolve the company s Quality Management System (QMS)
- Ensure ongoing compliance as the product develops (features, integrations, deployments)
- Work closely with product and engineering teams to embed compliance into development processes
- Act as the internal lead for ISO standards (including ISO 13485 and ISO 27001)
- Maintain audit readiness across documentation, policies, and controls
- Lead preparation for audits, inspections, and certifications
- Track and manage corrective and preventative actions (CAPAs)
- Maintain relevant certifications and regulatory approvals
- Manage relationships with external compliance partners and ensure delivery of key obligations
- Support clinical safety processes, including risk assessments and governance frameworks
- Act as a cross-functional partner, translating regulatory requirements into practical business decisions
Requirements
Experience
- Experience working within a regulated environment, ideally software as a medical device (SaMD)
- Strong knowledge of ISO standards, particularly ISO 13485 and ISO 27001
- Experience owning or contributing to a QMS
- Experience supporting audits and maintaining certifications
- Comfortable working in a fast-paced, product-led organisation
Location
London-based, with a hybrid working model (3 days in-office)
