The Regulatory Affairs Contractor will provide regulatory support for medical device portfolio and business integration activities. The role will work closely with Regulatory Affairs and cross-functional partners to support global regulatory planning, product registrations, lifecycle management, and execution of integration-related regulatory activities. The ideal candidate will have hands-on medical device Regulatory Affairs experience and be comfortable independently managing multiple global regulatory deliverables in a fast-paced, cross-functional environment.

Location: Remote - Colombia Only

About the Company

Abstra is a fast-growing, Nearshore Tech Talent services company, providing top Latin American tech talent to U.S. companies and beyond. Founded by U.S.-bred engineers with over 15 years of experience, Abstra specializes in sourcing skilled professionals across a wide range of technologies to meet our clients’ needs, driving innovation and efficiency.

Key Responsibilities




- Support regulatory activities associated with integration of medical device products and portfolios into existing business processes and systems.
- Develop, update, and maintain Global Regulatory Plans (GRPs) and associated regulatory documentation.
- Support global product registrations, renewals, license maintenance, and other market-specific regulatory requirements.
- Assess regulatory impact of product, manufacturing, labelling, supplier, site, and quality system changes.
- Support regulatory activities associated with legal manufacturer, manufacturing site, and quality system transitions, as applicable.
- Coordinate with regional Regulatory Affairs teams to identify country-specific requirements and execute regulatory actions necessary to maintain market access.
- Support EU MDR and other integral regulatory lifecycle activities, including technical documentation updates, assessments, submissions, and notifications, as applicable.
- Review existing regulatory documentation, identi

📌 Regulatory Affairs Contractor (Colombia)
🏢 Abstra
📍 Colombia