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, identify ga

📌 Regulatory Affairs Contractor (Colombia)
🏢 Abstra
📍 Colombia