Remote Regulatory Affairs Associate – Medical Devices

Medtronic; Colombia; A distancia; COP 60.000.000 - 90.000.000; Jornada completa

Descripción de la vacante

Medtronic is seeking an Associate Regulatory Affairs Specialist to support regulatory activities for medical devices across LATAM and APAC. This remote role based in Bogotá, Colombia focuses on documentation management, submissions, compliance, and coordination with stakeholders to advance registrations and commercialization.

The role requires a Bachelor's degree in a related field and 1–2 years of regulatory/quality experience, with fluent English for professional communication.

Formación

• Bachelor's degree completed or in progress in a related field.
• 1–2 years of professional experience in Regulatory Affairs or related functions preferred.
• Fluent English required for interviews and stakeholder interactions.
• Experience with documentation-intensive processes and regulatory submissions desirable.

Responsabilidades

• Coordinate and prepare documentation packages for regulatory submissions, audits, and inspections.
• Compile documentation for regulatory submissions, license renewals, and annual registrations.
• Review, organize, and maintain regulatory documentation across multiple document systems.
• Support responses to regulatory agency requests and gather required information.
• Partner with internal stakeholders and distributors to ensure timely regulatory activities.
• Monitor documentation status and ensure compliance with regulatory requirements.
• Suggest changes to labeling, manufacturing, marketing, and clinical protocols to support compliance.
• Stay informed on regulatory procedures and changes affecting the business.

Conocimientos

Fluent English

Documentation management

Regulatory coordination

Organization

Educación

Bachelor's degree in Healthcare, Bioengineering, Biotechnology, Pharmacy, Quality, or related fields

Herramientas

Microsoft Office

Descripción del empleo

Medtronic is seeking an Associate Regulatory Affairs Specialist to support regulatory activities for medical devices across LATAM and APAC. This remote role based in Bogotá, Colombia focuses on documentation management, submissions, compliance, and coordination with stakeholders to advance registrations and commercialization.

The role requires a Bachelor's degree in a related field and 1–2 years of regulatory/quality experience, with fluent English for professional communication.