Regulatory Affairs Specialist Consultant
Core
Provide operational and administrative support for regulatory documentation management and compliance for the Medical Devices portfolio in Colombia.
Role type
Entry-level Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory documentation packages for INVIMA submissions
Domain
Medical Devices / Regulatory Affairs (Colombia)
Deliverable
client delivery
Required skills
Regulatory documentation management, completeness checks, audit-ready file maintenance, regulatory plan execution support, system/database updates, project coordination, compliance with company policies
Preferred skills
Knowledge of Decree 4725 of 2005, Microsoft Office proficiency
Technologies
Microsoft Office tools
Responsibilities
Support collection and tracking of regulatory documentation for INVIMA submissions, Perform initial completeness checks of regulatory documentation, Maintain organized and audit-ready regulatory files, Assist with execution of approved regulatory plans under supervision, Update regulatory systems, databases, and trackers, Support coordination of regulatory projects and cross-functional requests
Seniority
Entry-level, supervised IC