Chief Regulatory Architect for AI & SaMD

Zest Scientific Recruitment; United Kingdom; Remote; GBP 120,000 - 180,000; Full time

Benefits offered by this job

Equity stake

Annual learning budget

Private healthcare

Pension or retirement contributions

Generous leave and wellbeing days

Job summary

Zest Scientific Recruitment is partnering with a high-growth digital health organisation to appoint a Head of Regulatory Affairs. This remote-first leadership role focuses on SaMD, AI-enabled medical devices and international market access, with a strong emphasis on embedding regulatory thinking into product development from day one.

You will lead regulatory strategy for UK and US markets, build scalable QMS, manage AI governance, and collaborate across Product, Clinical and Technology teams to

Qualifications

• Led regulatory strategy for software-based medical devices with UK/US market access.
• Experience with UK Class IIa/IIb and US Class II regulatory pathways, including submissions.
• Strong working knowledge of ISO 13485, ISO 14971 and IEC 62304; quality management and software development controls.
• Experience developing and maintaining technical documentation, risk management files and design history records.
• Understanding regulatory challenges for AI/ML-enabled medical devices, including validation and post-market monitoring.
• Led audits, CAPAs, and interactions with regulatory bodies; strengthened quality systems.
• Collaborated with Product, Clinical and Technology teams to embed regulatory requirements in development.

Responsibilities

• Define and deliver UK and US regulatory roadmap including classification and routes to market.
• Lead ISO 13485 quality management system development and integration into day-to-day operations.
• Prepare for Class II readiness across future higher-class devices.
• Develop governance for AI-enabled products, including validation and ongoing monitoring.
• Ensure technical documentation, clinical evaluation and risk management meet regulatory standards.
• Oversee audits, certifications, registrations and post-market surveillance.
• Partner with CEO, CTO, CPO and CMO to embed regulatory considerations in product discovery and release.

Skills

Regulatory strategy

UK & US market access

Quality management systems

ISO 13485

ISO 14971

IEC 62304

Regulatory documentation

Audits & CAPAs

AI/ML governance

Cross-functional leadership

Regulatory communications

Job description

Zest Scientific Recruitment is partnering with a high-growth digital health organisation to appoint a Head of Regulatory Affairs. This remote-first leadership role focuses on SaMD, AI-enabled medical devices and international market access, with a strong emphasis on embedding regulatory thinking into product development from day one.

You will lead regulatory strategy for UK and US markets, build scalable QMS, manage AI governance, and collaborate across Product, Clinical and Technology teams to