Regulatory Affairs Trainee
Core
Support Medical Device notification, registration, and post-approval activities for the Spanish market, including documentation preparation and labeling review.
Role type
Regulatory Affairs Trainee
Builds
Regulatory submissions and documentation for Medical Devices and Medicinal Products
Domain
Healthcare / Medical Devices / Pharmaceuticals
Deliverable
client delivery
Required skills
Regulatory documentation preparation, Medical Device labeling review, Translation coordination, Post-approval variation management
Preferred skills
CESIF Master's program background
Technologies
AEMPS systems
Responsibilities
Support Medical Device notification and registration with AEMPS; Collect and prepare regulatory documentation for tender submissions; Coordinate translation of Medical Device labeling materials; Review Medical Device labeling for Surgical and Vision Care portfolios; Support post-approval regulatory activities for Medicinal Products
Seniority
Entry-level / Trainee