GRA Device Associate - Medical Devices and Combination Products (all genders)
Core
Develop and implement global regulatory strategies for medical devices and combination products to ensure compliance and optimize approval pathways.
Role type
Senior regulatory affairs associate (medical devices)
Builds
Regulatory submissions and lifecycle management for medical devices and combination products
Domain
Biopharma / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy development, risk assessment, Health Authority interaction, submission planning, design control deliverables, change control management
Preferred skills
Cross-functional collaboration, strategic thinking, project management
Technologies
None stated
Responsibilities
Partner with Device Regulatory Lead on assigned projects, provide regulatory guidance to cross-functional teams, execute device regulatory strategies, support Health Authority interactions, identify regulatory risks and mitigation opportunities, support global filing and lifecycle management, liaise with internal business partners, prepare and review design control deliverables, contribute to product development planning, serve as regional regulatory lead as needed, support operational compliance activities
Seniority
Senior, hands-on IC
