Associate Director, Regulatory Affairs - Digital Health, Device & Combination Products (all gender)

Your Role

In this pivotal role, you will own and drive the global regulatory strategy for drug-device combination products, shaping the pathway from early development through to approval and lifecycle management. You will serve as the Device Regulatory Lead within a cross-functional regulatory strategy team, working in close partnership with CMC, device engineering, and quality colleagues to ensure compliant, timely, and scientifically credible submissions to health authorities worldwide. Your ability to build trusted relationships with regulatory agencies and to translate complex regulatory requirements into clear, actionable strategies will be central to accelerating the development of innovative combination products. Operating with considerable autonomy, you will influence both internal decision-making and external regulatory outcomes, contributing to a culture of regulatory excellence and risk-based thinking across the R&D organization.

Who You Are