Regulatory Affairs Strategist, Globalization (eIFU/ Est. Registrations)
Core
Strategic partner enabling aligned execution of global regulatory affairs strategies, processes, and best practices for labeling, eIFU, establishment registrations, and device listings across Business Units and Regions.
Role type
Senior Regulatory Affairs Strategist (Globalization)
Builds
Standardized global labeling and registration processes
Domain
Medical Device / Regulatory Affairs
Required skills
Global regulatory strategy, labeling management, eIFU expertise, establishment registration, device listing, process standardization, risk mitigation, cross-functional coordination, policy analysis
Preferred skills
Business and Regional role experience, Regulatory Affairs Certification (RAC), Master's degree in business/management/technology
Technologies
None stated
Responsibilities
Provide centralized regulatory governance for global labeling and information management; Develop and standardize labeling, eIFU, establishment registration, and device listing processes; Act as a strategic partner to Business Units and Regional Regulatory leaders; Coordinate and network across Business Units, Regions, and Central RA teams; Harmonize key processes and build communications channels; Aid in creation of risk mitigation plans; Identify common pain points and potential solutions; Stay apprised of global regulatory policy topics
Seniority
Senior, hands-on IC with strategic partnership focus