4h ago
Regulatory Affairs Specialist Consultant
Colombia
contractPharmaceutical / CRO
Tech Stack
Description
You will provide operational and administrative support for regulatory activities related to medical devices in Colombia. You'll assist with documentation management, system updates, and project coordination to ensure compliance with local regulations and client requirements.
Requirements
- Bachelor's degree in Life Sciences, Engineering, Pharmacy, or related field
- Basic understanding of Colombian medical device regulations (Decree 4725 of 2005)
- Proficiency in Microsoft Office tools
- Strong attention to detail
- Learning agility and proactive communication
Responsibilities
- Support collection and tracking of regulatory documentation for INVIMA submissions
- Perform initial completeness checks of regulatory documentation
- Maintain organized and audit-ready regulatory files
- Assist with execution of approved regulatory plans under supervision
- Update regulatory systems, databases, and trackers
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