Manager, Regulatory Affairs
Core
Lead regulatory strategy and ensure compliance for Thermo Fisher Brazil's medical devices, IVDs, SaMD, and other products with ANVISA and other Brazilian authorities.
Role type
Manager, Regulatory Affairs
Builds
Regulatory compliance and product registration for Brazil portfolio
Domain
Healthcare / Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy, ANVISA submissions, technical dossier preparation, cross-functional team leadership, Brazilian health legislation knowledge, impact assessment, database management
Preferred skills
Project management, strategic thinking, risk-based decision-making, negotiation, advanced Excel and AI tools
Technologies
JDE, RegDesk, DocNix, ANVISA systems
Responsibilities
Ensure regulatory compliance of operations and products; Execute regulatory strategy for new registrations and portfolio maintenance; Manage full regulatory submission process; Monitor regulatory updates and implement action plans; Partner with cross-functional teams; Manage Regulatory Affairs team in Brazil; Lead specific cross-regional projects
Seniority
Manager, leadership role
