- 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 - lucy.kirkaldy@cpl.com