Lead technical stewardship and lifecycle management of medical devices and drug-device combination products, including auto-injectors, prefilled syringes, and other injectable drug delivery systems.
Drive activities across late-stage development, technology transfer, commercialization, product maintenance, and retirement, ensuring product quality and supply continuity.
Act as the device subject matter expert, assessing device-drug compatibility, performance, patient safety risks, and compliance with global regulatory requirements.
Collaborate with suppliers, manufacturing sites, quality, regulatory, and development teams to resolve technical issues, manage changes, and support regulatory submissions and inspections.
Lead and mentor a team of specialists while ensuring inspection readiness, risk management, and successful delivery of strategic device programs across global markets.