Technical Product Lead - Regulatory Innovation
3 days ago
City of London
• Technical Product Lead – Regulatory Innovation, • London, UK - Hybrid We are seeking a hands-on, execution-focused Technical Product Lead – Regulatory Innovation to operate at the intersection of AI product development, clinical research, and regulatory strategy. 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 1. 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 1. 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)