Regulatory AI Innovation Leader

• Regulatory AI Innovation Leader
• London Area, United Kingdom (Hybrid)
• Competitive salary

We are seeking a hands-on, execution-focused Regulatory AI Innovation Leader to operate at the intersection of AI product development, clinical research, and regulatory strategy. Working for a stealth mode AI biotech developing rapidly. This role is ideal for individuals with a technical foundation in AI/ML or software engineering who have evolved into product and regulatory leadership within life sciences.

You will drive the development of fit-for-purpose, regulator-ready AI solutions used in clinical trials and clinical practice. A key focus will be enabling lean, scalable processes while advancing regulatory acceptance of novel AI methodologies. You will work cross-functionally across product, engineering, data science, clinical, and quality teams, and collaborate closely with regulatory stakeholders.

Key Responsibilities

1. Lean Quality & Process Enablement

• Partner with Quality to ensure the Quality Management System (QMS) is scalable, efficient, and minimally burdensome
• Embed quality and compliance into developer-native workflows
• Eliminate or refine controls that do not materially reduce risk
• Support teams in computerised system validation (CSV) from requirements definition through to validation and acceptance
• Provide pragmatic guidance, templates, and training on regulatory expectations without becoming documentation-driven
• Contribute to alignment across QMS, information security, and internal governance frameworks

2. Regulatory Innovation & Strategy

• Monitor and interpret the evolving regulatory landscape for AI in healthcare and clinical trials
• Identify opportunities to apply innovative AI approaches within regulatory frameworks
• Translate internal innovations into regulator-ready evidence packages and methodologies
• Support and participate in regulatory engagement activities (e.g., scientific advice, workshops, industry forums)
• Contribute to shaping emerging standards and expectations for AI validation and deployment

3. Product Leadership

• Translate user needs, regulatory requirements, and scientific insights into clear product requirements and acceptance criteria
• Collaborate with engineering, data science, and clinical teams to define and prioritise the product roadmap
• Own the end-to-end product lifecycle, ensuring alignment across commercial, scientific, and regulatory objectives
• Define and manage stage-gates to ensure readiness for validation, release, and scaling
• Track product performance and user outcomes, driving continuous improvement

Required Skills & Experience

• Degree in Engineering, Computer Science, or a related technical discipline
• Significant experience in product ownership and regulatory environments, ideally within:
• AI-enabled healthcare software
• Clinical trial systems
• Regulated digital products
• Strong understanding of quality, validation, and regulatory frameworks, such as:
• GxP / ICH-GCP
• Computerised system validation (CSV / GAMP 5)
• ISO standards (e.g., 13485, 14971, 62304)
• Data integrity and electronic records requirements
• Familiarity with emerging guidance on AI/ML in healthcare, including risk management and governance frameworks
• Proven ability to design lean, scalable processes that support high-velocity product delivery in regulated environments
• Technical fluency in AI/ML concepts, system architecture, and data pipelines
• Strong analytical thinking and problem-solving skills
• Ability to operate in cross-functional, fast-paced environments with a high degree of ownership

Preferred Experience

• Experience within clinical trials (sponsor, CRO, or technology provider)
• Exposure to regulatory interactions, submissions, or advisory processes
• Experience contributing to novel regulatory approaches or frameworks
• Knowledge of information security standards (e.g., ISO 27001, SOC 2)
• Experience supporting regulated product submissions (e.g., CE marking, FDA pathways)

What We’re Looking For

• A hybrid thinker who can bridge technology, product, and regulation
• A pragmatic, detail-oriented operator who prioritises execution over theory
• Someone who challenges complexity and drives lean, outcome-focused processes
• A confident communicator capable of engaging both technical teams and external stakeholders

Working Environment

• Cross-functional, collaborative environment at the intersection of AI and life sciences
• Opportunity to contribute to cutting-edge innovation in clinical research and healthcare
• Hybrid working model (location flexible depending on organisation)

For more information, please reach out - [email protected]