Flexible Work, Better Balance
**Regulatory Affairs Specialist**
**Position purpose**
Act as LRA (Local RA) for all the daily activities that will ensure registrations of Radiology Medical Devices are properly done in LATAM region by submitting local dossiers, keeping country requirement table and SharePoint site folder structure updated, and ensuring the proper trackers are up to date.
Keep the information flow between global RA and local business team by ensuring the proper trackers/slides are kept accurate and up to date and by communicating HA approvals (with impact details for new/old product versions).
Facilitate the communication between RA Regional Head and Commercial Country Heads.
Support assessments and labeling reviews from Global Regulatory Affairs (GRA) team for each regulated country within LATAM region.
**Main activities and responsibilities**
- Propose best strategy and execute dossier compilations and submissions (if applicable) according to HA (Health Authorities) an...