GRA Device Associate - Medical Devices and Combination Products (Senior Manager)
Core
Senior Manager leading global regulatory strategies for medical devices and combination products within Sanofi's R&D portfolio, ensuring compliance and optimizing approval pathways.
Role type
Senior Manager, Regulatory Affairs (Device & Combination Products)
Builds
Global regulatory strategies and submissions 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
Global regulatory strategy development, risk assessment, Health Authority interaction, cross-functional collaboration, design control deliverables, lifecycle management, regulatory impact assessment
Preferred skills
Advanced degree (Master or PhD), experience in pharmaceutical/biotechnology/medical device industry
Technologies
Regulatory submission platforms, design control tools
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 global filing and lifecycle activities, liaise with internal business partners, prepare design control deliverables, contribute to product development planning, provide regulatory impact assessments, serve as regional regulatory lead as needed, support operational compliance activities
Seniority
Senior Manager, strategic leadership & execution
