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Regulatory Affairs Specialist Consultant

Colombia

ClinChoice is searching for a Sr. Regulatory Affairs Specialist Consultant for a 12-month contract with the possibility of extension to join one of our clients.

ClinChoice is a integral full‑service CRO focused on quality, professional development, and a supportive culture. In this client‑facing role, you will work independently, building a high‑trust environment with the client’s counterparts.

The Regulatory Affairs Specialist I is responsible for providing operational and administrative support to Regulatory Affairs activities for the Medical Devices portfolio in Colombia. Under guidance from more senior regulatory professionals, this role supports regulatory documentation management, system updates, and project coordination to ensure compliance with applicable regulations and client internal requirements.

Key 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.
- Support coordination of regulatory projects and cross‑functional requests.
- Ensure compliance with company policies and procedures.

This role requires responsible handling of confidential and regulated information and is performed under supervision in alignment with established regulatory procedures.

Qualifications

- Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related field.
- Entry‑level role; prior internships or exposure to regulated environments is a plus.
- Basic understanding of Colombian medical device regulations (Decree 4725 of 2005).

Key Words: Regulatory Affairs, data analysis, EU MDD, EU MDR

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📌 Regulatory Affairs Specialist Consultant Colombia
🏢 ClinChoice
📍 Colombia