Assoc Regulatory Affairs Spec-11.

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

## Assoc Regulatory Affairs Spec-11.Postuler: À distance: Bogotá, Bogota, Colombia: Temps plein: Offre publiée aujourd'hui: Date de fin : 1 octobre 2026 (Il reste 5 jour(s) pour postuler): R76450Chez Medtronic, vous pouvez entamer une longue carrière d’exploration et d’innovation tout en aidant à soutenir l’accès aux soins de santé et l’équité pour tous. Vous dirigerez avec détermination en surmontant les obstacles à l’innovation dans un monde davantage connecté et compatissant.**Journée type**We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Work with us to incentivize better patient care and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide. As an Associate Regulatory Affairs Specialist, you will support regulatory activities for medical devices across LATAM and APAC. This role focuses on regulatory documentation management, submissions, compliance activities, and coordination with internal and external stakeholders to support product registrations and commercialization efforts. This is a remote role based in Bogotá, Colombia.**Responsibilities may include the following and other duties may be assigned:**· 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 requirement· Recommends changes related to labeling, manufacturing, marketing, and clinical protocols to support regulatory compliance· Stay informed on regulatory procedures, requirements, and changes affecting the business**Required Knowledge and Experience:**· Bachelor's degree completed or in progress, preferably in Healthcare, Bioengineering, Biotechnology, Pharmacy, Quality, Marketing, Business Administration, or related fields· 1-2 years of professional experience in Regulatory Affairs, Quality, Compliance, Documentation Management, Customer Service, Supply Chain, Legal, Administrative, or other related operational functions is preferred· Experience supporting documentation-intensive processes, submissions, registrations, compliance activities, or stakeholder management is desirable· Fluent English required; ability to communicate effectively in a professional environment as interviews and stakeholder interactions may be conducted in English· Proficiency in Microsoft Office applications, including Excel, Word, Outlook, and PowerPoint· Strong organizational skills with the ability to manage multiple priorities, deadlines, and documentation requirements simultaneously· Ability to work independently in a remote environment while collaborating effectively with internal and external stakeholders· Experience working in regulated industries such as medical devices, pharmaceuticals, healthcare, or related fields is preferredExigences physiques du posteLes déclarations ci-dessus visent à décrire la nature générale et le niveau du travail effectué par les employés affectés à ce poste, mais elles ne constituent pas une liste exhaustive de toutes les responsabilités et compétences requises pour ce poste.