Regulatory Affairs Jr Analyst Consultant (Medtech)

TL;DR

Regulatory Affairs Jr Analyst Consultant (Medtech): Ensures regulatory data compliance in databases, prepares labels, updates systems, and reviews regulatory data. Focus on supporting submissions, approvals of market licenses, and organizing regulatory activities.

Location: Colombia

Company

hirify.global is a global full-service CRO with a strong focus on quality, professional development, and supportive culture.

What you will do

• Execute post-approval activities, including reviewing databases and preparing communications to stakeholders.
• Update systems with regulatory data and documents.
• Review label compliance in the internal system.
• Execute submissions of changes, amendments, rectifications, and renewals in a timely manner with guidance.
• Provide assistance with establishment registration licenses.
• Support regional team on product submissions schedules, prioritization, and pipeline management with guidance.

Requirements

• A Bachelor’s Degree in Engineering, Pharmacy, or other life science, or equivalent combination of education and experience.
• Desirable experience working in a Regulatory Environment, preparing submissions for Colombian Health Authorities.
• Desirable experience in health care companies.
• Intermediate writing and reading skills in English.
• Ability to manage complex data with excel spreadsheets are desirable.

Culture & Benefits

• Working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring.
• Strong focus on quality, professional development, and supportive culture.
• Client-facing role with the ability to work independently.