Remote Regulatory Affairs Associate - Global Med Devices

Medtronic plc; Bogotá ciudad; Híbrido; COP 66.960.000 - 100.440.000; Jornada completa

Descripción de la vacante

Medtronic plc is hiring an Associate Regulatory Affairs Specialist for a remote role based in Bogotá, Colombia. The role supports regulatory activities for medical devices across LATAM and APAC, focusing on documentation management, submissions, and compliance to enable product registrations and commercialization.

We seek candidates with 1-2 years of related experience, fluent English, and strong MS Office skills. The position requires independent remote work and collaboration with global teams.

Formación

• Bachelor's degree completed or in progress in related field.
• 1-2 years of regulatory affairs or related experience preferred.
• Fluent English for professional communication.
• Proficiency in MS Office (Excel, Word, Outlook, PowerPoint).
• Experience with documentation-intensive processes and submissions.

Responsabilidades

• Coordinate and prepare documentation packages for regulatory submissions, audits, and inspections.
• Compile documentation required for regulatory submissions, license renewals, and annual registrations.
• Review, organize, upload, and maintain regulatory documentation across multiple document management systems.
• Support responses to regulatory agency requests by collecting and submitting required information and documentation.
• Partner with internal stakeholders, regulatory teams, consultants, and distributors to ensure timely completion of regulatory activities.
• Monitor documentation status and support compliance with regulatory requirements.

Conocimientos

Regulatory Affairs

Documentation Management

Stakeholder Management

English Fluency

MS Office

Educación

Bachelor's degree

Herramientas

Microsoft Office Suite

Excel

PowerPoint

Word

Outlook

Descripción del empleo

Medtronic plc is hiring an Associate Regulatory Affairs Specialist for a remote role based in Bogotá, Colombia. The role supports regulatory activities for medical devices across LATAM and APAC, focusing on documentation management, submissions, and compliance to enable product registrations and commercialization.

We seek candidates with 1-2 years of related experience, fluent English, and strong MS Office skills. The position requires independent remote work and collaboration with global teams.