Regulatory Affairs Specialist 3, LATAM
Core
Support planning, execution, and maintenance of regulatory activities for medical device product registrations and lifecycle management across Latin America.
Role type
Senior Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory submissions and product registrations for medical devices in LATAM markets
Domain
Medical Devices / Healthcare / Latin America
Deliverable
client delivery
Required skills
Regulatory strategy, product registration, regulatory impact assessment, health authority interaction, cross-functional collaboration, document management, risk analysis, project management
Preferred skills
Veeva Vault, TrackWise, Agile
Technologies
Veeva Vault, TrackWise, Agile
Responsibilities
Develop and execute regulatory strategies for new product registrations and license renewals; Prepare and coordinate product registration dossiers and change notifications; Conduct regulatory assessments for product changes and monitor evolving regulations; Collaborate with cross-functional teams including Quality, R&D, and Commercial; Maintain regulatory databases and submission trackers.
Seniority
Senior, hands-on IC