Associate Regulatory Affairs Specialist
On-siteBogotá, Bogota D.C., Colombia
Job Summary
Coordinate and prepare documentation packages for regulatory submissions, audits, and inspections across LATAM and APAC. Compile materials for license renewals and annual registrations while reviewing, organizing, and maintaining records across multiple document management systems. Support responses to regulatory agency requests by collecting and submitting required information, partnering with internal stakeholders, consultants, and distributors to ensure timely completion of activities. Monitor documentation status to support compliance with regulatory requirements and recommend changes related to labeling, manufacturing, and clinical protocols. This remote role in Bogotá focuses on product registrations and commercialization efforts for medical devices. Fluent English proficiency is required for effective stakeholder interactions.
Required Qualifications
- Bachelor's degree completed or in progress, preferably in Healthcare, Bioengineering, Biotechnology, Pharmacy, Quality, Marketing, Business Administration, or related fields
- Fluent English
- Proficiency in Microsoft Office applications, including Excel, Word, Outlook, and PowerPoint
- Strong organizational skills with the ability to manage multiple priorities, deadlines, and documentation requirements simultaneously
- Ability to work independently in a remote environment while collaborating effectively with internal and external stakeholders
- This is a remote role based in Bogotá, Colombia
Desired Qualifications
- 1-2 years of professional experience in Regulatory Affairs, Quality, Compliance, Documentation Management, Customer Service, Supply Chain, Legal, Administrative, or other related operational functions
- Experience supporting documentation-intensive processes, submissions, registrations, compliance activities, or stakeholder management
- Experience working in regulated industries such as medical devices, pharmaceuticals, healthcare, or related fields
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