Compliance Manager - Healthcare AI Solutions

About the Role

We are seeking a Compliance Manager to join our team at Tortus, a pioneering company in the healthcare AI space. As a Compliance Manager, you will play a crucial role in ensuring that our innovative AI clinical co-pilot meets all regulatory requirements while enhancing clinician efficiency. This Compliance Manager remote position will allow you to work closely with product, engineering, and operations teams to maintain compliance with Class II medical device regulations.

What You'll Do

• Own Class II medical device compliance and act as the internal lead for regulatory requirements and standards.
• Manage and evolve our Quality Management System (QMS) to ensure our product remains compliant as it evolves.
• Work closely with product and engineering teams to embed compliance into our development processes.
• Serve as the point person for ISO 13485 and ISO 27001 compliance, maintaining standards through internal audits and process updates.
• Prepare for audits and regulatory inspections, ensuring documentation and controls are audit-ready at all times.
• Manage external compliance relationships, including DPO, DSPT, and Cyber Essentials Plus.
• Support clinical safety processes and act as a point of contact for clinical safety queries.
• Translate regulatory requirements into practical decisions that support customer and NHS-facing compliance processes.

Requirements

• Experience in Class II medical device or SaMD compliance.
• Strong working knowledge of ISO 27001, 13485, and broader ISO frameworks.
• Experience owning or contributing to a QMS and supporting audits.
• Comfortable operating in a fast-moving, product-led environment.
• Ability to work closely with product and engineering teams.

Nice to Have

• Clinical background or experience working closely with clinical teams.
• Experience as a Clinical Safety Officer (CSO) or willingness to become one.
• Exposure to AI or data-driven healthcare products.
• Familiarity with NHS requirements (e.g., DSPT, DTAC).

What We Offer

• Competitive base salary, plus commission and bonus with upside.
• Meaningful equity in an early-stage company with strong NHS traction.
• Opportunity to help scale a company with proven clinical outcomes.
• Join a small, growing Commercial team and help define how we sell.
• Be part of a mission to give clinicians back their time, improving patient care at scale.