Analista de Asuntos Regulatorios – Registros Sanitarios

About the role

The Regulatory Affairs Analyst will manage all regulatory processes related to health product registrations, pre‑qualification, and compliance with Costa Rican authorities. The role supports the General Management with administrative tasks and ensures timely submission of technical documentation.

Key responsibilities

• Review and prepare dossiers for registration, renewal, and modification of medical devices, medicines, cosmetics, and dietary supplements.
• Submit and follow up regulatory files with the Ministry of Health and address observations from the health authority.
• Coordinate pre‑qualification processes with the Costa Rican Social Security (CCSS), including sample shipment and dossier preparation.
• Perform basic Spanish‑English translations of technical documents and manage certified copy requests.
• Collaborate with Commercial, Quality, and Legal departments to keep technical documentation up‑to‑date and compliant.

Required profile

• Bachelor’s degree in Pharmacy, Chemistry, Biotechnology, or related field.
• Minimum 2 years of experience in regulatory affairs, preferably in pharmaceuticals or medical devices.
• Strong knowledge of Costa Rican health legislation and regulatory procedures.
• Detail‑oriented, analytical, and able to work under tight deadlines.

Required skills

• Microsoft Word
• Microsoft Excel
• Microsoft Outlook
• Spanish‑English technical translation