Regulatory Affairs & Quality Manager

Full TimeRemote

BogotáRemotePosted 16 days ago

Role Overview

Distro is hiring a Regulatory Affairs & Quality Manager. This is a full-time remote role, with the team based in Bogotá. Part of Distro's Qa hiring, posted 2 weeks ago. Full responsibilities, required qualifications, and the apply link are listed in the description below.

Salary Context

Salary is not disclosed in this posting. Market median for Qa roles is $120k-$168k (based on 429 comparable listings). Many employers share specifics during the interview process or after an initial screen.

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ComplianceEstamosQARACalidadAsuntosRegulatoriosColombia

Job description

Estamos buscando un QA & RA Manager para liderar y gestionar de manera transversal los procesos de Calidad y Asuntos Regulatorios en Colombia y LATAM, asegurando el cumplimiento normativo, la implementación del sistema de gestión de calidad y el control regulatorio ante autoridades sanitarias.

Responsabilidades principales ** Liderar la implementación, mantenimiento y mejora del sistema de gestión de calidad (QMS). Garantizar el cumplimiento de regulaciones locales e internacionales para dispositivos médicos e IVD. Supervisar procesos regulatorios: registros, modificaciones, renovaciones y gestión documental. Asegurar la trazabilidad, almacenamiento y distribución adecuada de productos. Gestionar reportes de calidad, eventos adversos, quejas y retiros de producto del mercado. Coordinar auditorías, certificaciones y la relación con entidades regulatorias.

Requisitos del puesto Formación: Profesional en Bacteriología o carreras del área de la salud. Deseable posgrado en Calidad o áreas afines. Experiencia: Entre 5 y 7 años en roles de Calidad y/o Asuntos Regulatorios. Experiencia en regulación sanitaria colombiana y dispositivos médicos. Idiomas: Inglés intermedio / avanzado Conocimiento: Sistemas de gestión de calidad (ISO 9001 y/o ISO 13485). Procesos regulatorios, registros sanitarios y compliance.

Condiciones: Disponibilidad de viajes nacionales e internacionales. Modalidad hibrida

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About Distro

Distro

distro.io

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Frequently Asked Questions

How do I apply for the Regulatory Affairs & Quality Manager position at Distro?

Use the Apply button above to submit your application directly to Distro. Most applications take less than 5 minutes if your resume and contact details are ready, and you'll be routed to the employer's official application system to finish.

Is the Regulatory Affairs & Quality Manager role at Distro remote?

Yes. This is a remote role. The team is based in Bogotá, but the position itself does not require relocating to that office.

What does a Regulatory Affairs & Quality Manager at Distro earn?

Distro has not disclosed a salary range in this posting. Many employers share specifics later in the interview process; you can also ask during a recruiter screen if compensation transparency is important to you.

When was the Regulatory Affairs & Quality Manager role at Distro posted?

This role was posted on June 27, 2026 (16 days ago). It's still listed as actively hiring; we re-confirm openings against the source system multiple times per day and remove closed roles.

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