Regulatory AI Product Lead - Lean, Impactful Drug Dev

Cpl Life Sciences; Greater London; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

Cpl Life Sciences is seeking a Product Lead, Regulatory Innovation (AI) in West London with a hybrid work model. You will own regulatory-focused product strategy at the intersection of AI/medical device software and drug development.

You will partner with Quality, regulatory, and engineering teams to drive lean QMS adoption, map innovations to regulator-ready dossiers, and represent the company in regulator-facing forums. A hands-on, technical background in AI/ML is preferred.

Qualifications

• Master's degree in Engineering, Computer Science or a related technical discipline.
• Minimum 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.
• Strong understanding of quality management systems and relevant regulatory standards for AI in clinical practice and trials.
• Knowledge of computerised system validation in clinical trials and standards such as ICH E6 (GCP), ISO 13485, 21 CFR Part 11, and FDA/EU AI guidance.
• Analytical, problem-solving skills and ability to create low-burden processes for high-velocity lifecycles.
• Technical roots in AI/ML implementation; capable of engaging with engineers and data scientists on models and data pipelines.
• Entrepreneurial and empowered.

Responsibilities

• Lean (QMS) process advocacy; scale QMS without impacting product velocity.

Skills

AI/ML roots

Regulatory ownership

Quality systems knowledge

Validation knowledge

Regulatory standards

Analytical skills

Technical liaison

Entrepreneurial

Education

Master's degree in Engineering, Computer Science or related technical discipline

Job description

Cpl Life Sciences is seeking a Product Lead, Regulatory Innovation (AI) in West London with a hybrid work model. You will own regulatory-focused product strategy at the intersection of AI/medical device software and drug development.

You will partner with Quality, regulatory, and engineering teams to drive lean QMS adoption, map innovations to regulator-ready dossiers, and represent the company in regulator-facing forums. A hands-on, technical background in AI/ML is preferred.