Regulatory Affairs – Quality Manager

Distro

QA & RA Manager leading quality and regulatory affairs for medical devices in Colombia and LATAM. Ensuring compliance and managing the quality management system effectively.

Posted 6/29/2026full-timeBogotá • 🇨🇴 ColombiaMid-LevelSenior💰 COP 1 per monthWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Distro Website LinkedIn All Job Openings 1 - 10 employees Founded 2021 👥 HR Tech 🎯 Recruiter ☁️ SaaS HR Tech
Recruitment
SaaS Distro is an AI-driven recruiting platform designed to automate and streamline the hiring process for companies of all sizes. By leveraging smart automation, Distro helps teams quickly vet resumes, conduct structured video interviews, and match candidates to job requirements, enabling efficient and effective hiring. Catering to startups, remote-first companies, and enterprise talent teams, Distro enhances recruitment by reducing manual tasks and facilitating international hiring through its employer of record services. Regulatory Affairs – Quality Manager Job not on LinkedIn 🔥 36 minutes ago 🏢🏡 Bogotá – Hybrid 💵 $1 / month ⏰ Full Time 🟡 Mid-level 🟠 Senior 🚔 Compliance 🗣️🇪🇸 Spanish Required Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
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. 🎯 Requirements
Profesional en Bacteriología o carreras del área de la salud.
Deseable posgrado en Calidad o áreas afines.
Entre 5 y 7 años en roles de Calidad y/o Asuntos Regulatorios.
Experiencia en regulación sanitaria colombiana y dispositivos médicos.
Inglés intermedio / avanzado.
Conocimiento en Sistemas de gestión de calidad (ISO 9001 y/o ISO 13485).
Procesos regulatorios, registros sanitarios y compliance. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Compliance Officer 🕒 June 11 dLocal 201 - 500 💳 Fintech 🛍️ eCommerce Website LinkedIn All Job Openings Compliance Officer overseeing regulatory compliance and AML/KYC controls for fintech operations in Colombia. Engaging in local regulatory bodies and maintaining compliance documentation and training. 🏢🏡 Bogotá – Hybrid 💰 $150M Venture Round on 2021-04 ⏰ Full Time 🟡 Mid-level 🟠 Senior 🚔 Compliance 🗣️🇪🇸 Spanish Required View More Compliance Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Gestión De CalidadRegistros SanitariosComplianceAuditoríasCertificacionesTrazabilidadAlmacenamientoDistribución De ProductosISO 9001ISO 13485

Certifications

Posgrado En Calidad