Regulatory Affairs Contractor – Medical Devices (Remote, Colombia)

About the role

Abstra, a nearshore tech talent services company, is hiring a Regulatory Affairs Contractor to support medical device portfolio and business integration activities. The role works closely with Regulatory Affairs and cross-functional partners on global regulatory planning, product registrations, lifecycle management and integration-related regulatory work. It is fully remote and open to Colombia only.

Key responsibilities

• Support regulatory activities for integrating medical device products and portfolios into existing business processes and systems.
• Develop, update and maintain Global Regulatory Plans (GRPs) and their documentation.
• Support global product registrations, renewals, license maintenance and market-specific requirements.
• Assess the regulatory impact of product, manufacturing, labelling, supplier, site and quality system changes.
• Support legal manufacturer, manufacturing site and quality system transitions where applicable.
• Coordinate with regional Regulatory Affairs teams on country-specific requirements and market access.
• Support EU MDR and other lifecycle activities such as technical documentation updates, assessments, submissions and notifications.
• Review regulatory documentation, identify gaps and coordinate corrective actions.
• Maintain regulatory trackers, plans and deliverables within timelines.
• Partner with Quality, Operations, R&D, Clinical and Supply Chain, and escalate regulatory risks and dependencies.

Required profile

• Bachelor's degree in life sciences, engineering, Regulatory Affairs or a related field.
• 3-5+ years of medical device Regulatory Affairs experience preferred.
• Experience with global medical device registrations and lifecycle management.
• Ability to manage multiple regulatory deliverables independently and work across global teams.

Required skills

• Working knowledge of FDA medical device requirements and EU MDR; experience with other international markets preferred.
• Regulatory change assessments, global regulatory planning and integration activities preferred.
• Class II/III devices, GRPs, EU MDR and portfolio integration highly desirable.

What we offer

• Competitive compensation paid in USD.
• 20 days of paid time off per year.
• Professional growth opportunities and company-provided equipment.
• A collaborative, inclusive, multicultural environment.