Product Lead, Regulatory Innovation (AI)

Job Title: Product Lead, Regulatory Innovation (AI)

Location: West London, UK – Hybrid

Job Type: Full-time, permanent

Remuneration: Competitive salary and benefits

Cpl Life Sciences is partnering with a growing, innovative AI biotech operating at the interface of drug development and drug device development. They are looking for a hands-on, pragmatic, and detail-oriented product lead focused on regulatory innovation. A lean, execution-focused approach is critical.

The role is ideally suited to people with technical roots (AI/ML software development) who have grown into regulatory ownership within life sciences. Your ambition will be to achieve lean process implementation as well as regulatory innovation, supporting the company's engagement with regulatory agencies for the acceptance of fit-for-purpose AI solutions.

The company builds generative AI solutions for clinical trials and clinical practice, spanning in vitro diagnostics, clinical decision support, and assessments embedded in late-stage clinical trials. Its products operate at the intersection of several regulatory regimes, including IVDR, MDR/SaMD, ICH E6 (R3) GCP, 21 CFR Part 11, the EU AI Act, and the emerging FDA and EMA frameworks for AI in drug development.

Responsibilities

Lean (QMS) process advocacy

• Partner with the Quality Lead to ensure the Quality Management System (QMS) scales without crushing product velocity (efficient, low-burden, scalable and fit-for-purpose).
• Embed quality work into developer-native workflows, including retiring controls that are not supporting risk mitigation.
• Conversely, support the product teams in computerised system validation, from user requirements and risks to validation testing and acceptance criteria.
• Enable teams through training, templates and pragmatic guidance on regulatory expectations, without ever turning into the documentation team.
• Contribute to alignment across the QMS, information security (ISO 27001 / SOC 2) and HR/handbook frameworks so colleagues see one coherent system.

Regulatory innovation and methodology

• Screen and monitor the relevant regulatory landscape with a focus on compliance, while evaluating opportunities to embed innovative AI solutions in drug development and clinical product strategies.
• Partner with the science and AI teams to (1) map innovations against regulatory opportunities, and (2) package methodological evidence into regulator-ready dossiers for qualification, submission and/or engagement with regulators.
• Represent the company in industry and regulator-facing forums on AI in clinical trials (FDA workshops, EMA stakeholder meetings, DIA, ICH working groups, etc.).
• Support engagement with regulators on the acceptability of new AI methodologies and their validation for clinical trials and/or clinical solutions, e.g. FDA (Type B/C meetings, CDER/CBER), EMA (Scientific Advice, Innovation Task Force, CHMP qualification advice and qualification opinion procedures) and MHRA.

Product management

• Translate user feedback, regulatory input, scientific literature and market insights into clear product requirements, improvements and acceptance criteria.
• Collaborate with the engineering, algorithm and science teams to shape the product roadmap.
• Own the product lifecycle from concept to launch and iteration, with clear stage-gates that satisfy commercial, scientific and regulatory needs.
• Monitor product performance and user outcomes and drive continuous improvements.

Required skills and qualifications

Essential

• Master's degree in Engineering, Computer Science or a related technical discipline. An additional qualification in Quality or Regulatory Affairs is a plus.
• At least 7 years' combined experience in (technical) product ownership and regulatory, ideally AI-driven medical device software or clinical-trial computerised systems (with a focus on AI solutions) used in pivotal drug development.
• Strong understanding of quality management systems and relevant regulatory standards in relation to AI for both clinical practice and trials.
• Working knowledge of computerised system validation in clinical trials, ICH E6 (GCP), GAMP 5, ISO 13485, ISO 14971, IEC 62304 and 21 CFR Part 11. Familiarity with AI-specific quality and risk frameworks: FDA AI/ML SaMD Action Plan and FDA guidance on AI in drug development, EU AI Act, ISO/IEC 42001 and NIST AI RMF.
• Strong analytical and problem-solving skills, with a track record of creating low-burden processes for high-velocity product lifecycles.
• Technical roots in AI/ML implementation; able to engage credibly with engineers and data scientists on model architecture, data pipelines and validation.
• Entrepreneurial and empowered.

Bonus

• Operational clinical-trial experience on the sponsor, CRO or regulator side.
• Proven track record of engaging with regulators to shape guidance on novel methodologies and contribute to evolving regulatory frameworks.
• Experience with information security guidelines (ISO 27001, SOC 2, etc.).
• Experience in preparing CE or FDA 510(k) / De Novo submissions.

For more information, please reach out to me at [email protected]