GRA Device Associate, Medical Devices and Combination Products
Core
Develop and implement global regulatory strategies for medical devices and combination products within the Sanofi portfolio, ensuring compliance across the product lifecycle.
Role type
Senior Regulatory Affairs Associate (Medical Devices & Combination Products)
Builds
Regulatory submissions and strategies for medical devices, combination products, and IVDs
Domain
Biopharmaceuticals / Medical Devices / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device regulatory strategy, Health Authority interaction, regulatory filing execution, risk assessment, design control deliverables, lifecycle management, change control impact assessment
Preferred skills
Graduate degree in scientific/engineering discipline, experience with drug administration devices, matrix environment collaboration
Technologies
None explicitly listed
Responsibilities
Partner with Device Regulatory Lead on assigned projects, provide regulatory guidance to cross-functional teams, execute medical device regulatory strategies, support Health Authority interactions, identify regulatory acceleration opportunities and risks, manage submission timelines and content plans, liaise with internal business partners, prepare design control deliverables, contribute to product development planning
Seniority
Mid-Senior, hands-on IC
