Head of Regulatory

Head of Regulatory | Digital Health | London (Hybrid) 

Job ID: 97832 

A fast-growing UK health-tech company is seeking an experienced Head of Regulatory to lead and operationalise regulatory, quality, and compliance systems as a core part of product development. 

This senior, hands-on leadership role will own the organisation’s regulatory framework across medical device quality, clinical safety, information security, and data protection. The successful candidate will embed compliance directly into engineering and product workflows, ensuring audit readiness while enabling rapid, safe innovation. 

This is an opportunity to join a scaling AI-driven healthcare company where regulatory excellence is positioned as a strategic capability and competitive differentiator rather than a support function. 

Your responsibilities as Head of Regulatory will include: 

• Owning and operating the company Quality Management System (QMS) within a software medical device environment  
• Maintaining and expanding compliance across ISO 13485, ISO 27001, NHS and international regulatory frameworks  
• Embedding software lifecycle and risk management standards into product and engineering workflows  
• Leading audit preparation, certification activities, and ongoing compliance monitoring  
• Ensuring continuous audit readiness across quality, clinical safety, and information security domains  
• Managing regulatory approvals and routine compliance decisions related to product releases  
• Leading DPIAs, privacy risk assessments, and vendor compliance reviews  
• Supporting cybersecurity and privacy-by-design implementation aligned with GDPR and HIPAA expectations  
• Acting as primary contact for auditors, certification bodies, and customer compliance inquiries  
• Developing SOPs, governance processes, and scalable compliance documentation  
• Managing and mentoring regulatory team members while building internal capability  
• Partnering closely with Product, Engineering, Security, and senior leadership teams  

To be successful as Head of Regulatory, you will demonstrate: 

• Significant hands-on experience operating SaMD quality systems  
• Experience delivering or maintaining ISO 13485 certification in a software environment  
• Strong knowledge of ISO 14971 risk management and IEC 62304 software lifecycle requirements  
• Practical experience with ISO 27001, GDPR, and healthcare data protection frameworks  
• Experience leading audits and working with certification bodies or regulators  
• Ability to balance regulatory rigour with pragmatism in fast-moving environments  
• Previous leadership or team management experience within QA/RA or compliance functions  
• Strong stakeholder communication skills across technical and non-technical teams  

Experience with NHS standards (e.g., DSPT, clinical safety standards) or US frameworks such as SOC 2 or HIPAA is advantageous. 

Why apply? 

• Senior leadership role with direct organisational impact  
• Opportunity to shape regulatory strategy within an AI-enabled healthcare platform 
• Hybrid working environment in London  
• Collaborative, mission-driven health-tech culture  
• Competitive salary and benefits package  

Head of Regulatory | Regulatory Director | QA/RA Lead | SaMD | Digital Health | ISO 13485 | ISO 27001 | IEC 62304 | ISO 14971 | GDPR | Clinical Safety | HealthTech | AI Healthcare | London | Hybrid | Start-up | Regulatory Leadership