Regulatory Affairs Specialist Consultant

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Sr. Regulatory Affairs Specialist Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing 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 Affairs professionals, this role supports regulatory documentation management, systems updates, and project coordination to ensure compliance with applicable regulations and Clients 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.

Qualifications

Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or 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).

•
Proficiency in Microsoft Office tools.
Manejo de herramientas Microsoft Office.

• Strong attention to detail and willingness to learn.
Alta atención al detalle y disposición para aprender.

Core Competencies & Behaviors / Competencias y Comportamientos Clave

• Learning agility and curiosity.
Agilidad de aprendizaje y curiosidad.

• Attention to detail.
Atención al detalle.

• Accountability for assigned tasks.
Responsabilidad sobre las tareas asignadas.

• Collaboration with cross-functional teams.
Colaboración con equipos multifuncionales.

• Proactive communication.
Comunicación proactiva.

Other Information / Información Adicional

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

Este cargo requiere el manejo responsable de información confidencial y regulada y se desempeña bajo supervisión, de acuerdo con los procedimientos regulatorios establecidos.

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