ClinChoice - Regulatory Affairs Specialist Consultant
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Requirements
• 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 • Key Words:
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.
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