Regulatory Affairs Specialist III | Costa Rica
Core
Develops and executes regulatory strategies for medical device product portfolios across Costa Rica and Central America to ensure timely approvals and compliance.
Role type
Senior Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory submissions and compliance strategies for medical devices
Domain
Medical Devices / Healthcare
Required skills
Medical device regulatory submissions, Central American health authority interactions, regulatory intelligence, risk management, localization of labeling, cross-functional coordination, database management, scientific analysis
Preferred skills
Global or LATAM regulations knowledge, regulatory advocacy
Technologies
Regulatory databases, business systems
Responsibilities
Develop local regulatory approval strategies, coordinate and submit regulatory filings, review product changes for compliance, monitor regulatory developments, lead cross-functional coordination, maintain regulatory information systems, coordinate labeling localization, review promotional materials, serve as RA point of contact for consultants
Seniority
Mid-Senior, hands-on IC