At a Glance
- Tasks: Lead AI innovation in regulatory strategies for clinical trials and healthcare.
- Company: Stealth mode AI biotech focused on cutting-edge solutions.
- Benefits: Competitive salary, hybrid work model, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on innovation and lean processes.
- Why this job: Make a real impact at the forefront of AI in healthcare.
- Qualifications: Degree in Engineering or Computer Science; experience in product ownership and regulatory environments.
The predicted salary is between 80000 - 100000 £ per year.
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. 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- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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).
Regulatory AI Innovation Leader in London employer: Cpl Life Sciences
Join a pioneering AI biotech firm in the London Area, where innovation meets regulatory excellence. As a Regulatory AI Innovation Leader, you'll thrive in a collaborative, cross-functional environment that champions cutting-edge solutions in clinical research. With a hybrid working model and a focus on employee growth, this role offers a unique opportunity to shape the future of healthcare while enjoying a supportive culture that values execution and creativity.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory AI Innovation Leader in London
✨Tip Number 1
Network like a pro! Connect with folks in the AI and regulatory space on LinkedIn or at industry events. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Show off your skills! Create a portfolio or a project that highlights your experience in AI product development and regulatory strategy. This will give you something tangible to discuss during interviews and set you apart from the crowd.
✨Tip Number 3
Prepare for those interviews! Research the company and its products, especially how they align with regulatory frameworks. Be ready to discuss how your background in AI/ML can drive innovation in clinical trials.
✨Tip Number 4
Don’t forget to apply through our website! We’re always on the lookout for talent that can help us push the boundaries of AI in healthcare. Your next big opportunity could be just a click away!
We think you need these skills to ace Regulatory AI Innovation Leader in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV speaks directly to the role of Regulatory AI Innovation Leader. Highlight your experience in AI/ML, product ownership, and regulatory environments. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about AI in healthcare and how your skills can drive innovation at StudySmarter. Keep it engaging and relevant to the job description.
Showcase Your Technical Skills:Don’t shy away from detailing your technical expertise in AI/ML and software engineering. We’re looking for someone who can bridge the gap between tech and regulation, so make sure we see that in your application!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your AI and Regulatory Stuff
Make sure you brush up on the latest trends in AI and regulatory frameworks, especially those related to healthcare. Be ready to discuss how your technical background in AI/ML or software engineering can translate into practical solutions for regulatory challenges.
✨Showcase Your Cross-Functional Skills
This role requires collaboration across various teams. Prepare examples of how you've successfully worked with product, engineering, and clinical teams in the past. Highlight your ability to communicate effectively with both technical and non-technical stakeholders.
✨Demonstrate Lean Process Thinking
Be prepared to discuss how you've designed lean, scalable processes in previous roles. Think about specific instances where you eliminated unnecessary steps or refined controls to enhance efficiency while maintaining compliance.
✨Engage with Regulatory Insights
Familiarise yourself with current regulatory expectations for AI in healthcare. Be ready to share your thoughts on emerging standards and how you can contribute to shaping these frameworks. Showing that you're proactive about regulatory engagement will set you apart.
