Remote Medical Device Regulatory Affairs Contractor

Abstra; Colombia; A distancia; COP 186.840.000 - 311.400.000; A tiempo parcial

Ventajas ofrecidas por este puesto de trabajo

USD pay

PTO 20 days

Career growth opportunities

Equipment provided

Inclusive, multicultural environment

Descripción de la vacante

Abstra is seeking a Regulatory Affairs Contractor to provide regulatory support for its medical device portfolio and integration activities. The role collaborates with Regulatory Affairs and cross-functional partners to plan global regulatory activities, registrations, and lifecycle management in a fast-paced environment.

The ideal candidate has hands-on medical device regulatory affairs experience, can independently manage multiple global deliverables, and is comfortable operating across

Formación

• Bachelor's degree in life sciences, engineering, Regulatory Affairs, or a related discipline.
• 3–5+ years of medical device Regulatory Affairs experience.
• Experience with global medical device registrations and lifecycle management.
• Knowledge of FDA requirements and EU MDR; international markets a plus.
• Ability to independently manage multiple deliverables with global teams.
• Strong organizational and written communication skills.

Responsabilidades

• Support regulatory activities for medical device products during integration.
• Develop and maintain Global Regulatory Plans (GRPs) and docs.
• Support registrations, renewals, licenses and market-specific requirements.
• Assess regulatory impact of changes to product, manufacturing, labeling, site, or quality system.
• Coordinate with regional teams to meet country requirements.
• Support EU MDR and other lifecycle activities, including doc updates and submissions.
• Maintain regulatory trackers and deliverables to deadlines.
• Collaborate with Quality, Operations, R&D, Supply Chain and others.
• Identify and escalate regulatory risks affecting timelines.

Conocimientos

Regulatory affairs

Project management

Cross-functional collaboration

Regulatory documentation

Attention to detail

Educación

Bachelor's degree in life sciences/Regulatory Affairs

Herramientas

Regulatory submissions platforms

Descripción del empleo

Abstra is seeking a Regulatory Affairs Contractor to provide regulatory support for its medical device portfolio and integration activities. The role collaborates with Regulatory Affairs and cross-functional partners to plan global regulatory activities, registrations, and lifecycle management in a fast-paced environment.

The ideal candidate has hands-on medical device regulatory affairs experience, can independently manage multiple global deliverables, and is comfortable operating across