Regulatory Affairs & Quality Manager

Distro
Bogotá
Workplace: HybridFull timeCOP 1 - 1 monthlyFunction: Quality & Regulatory (Non-Software)Experience: 5-7 yearsSkills: []

Lead cross-functional quality and regulatory processes in Colombia and LATAM, ensuring compliance with local and international requirements for medical devices and IVD. Own and continuously improve the QMS (ISO-based), manage regulatory submissions and documentation (registrations, updates, renewals), and ensure product traceability, storage, and distribution. Oversee quality reporting, adverse events, complaints, and market withdrawals, coordinating audits, certifications, and relationships with regulatory authorities.

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FursaFursa
Distro
Distro
1 month ago

Regulatory Affairs & Quality Manager

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Source: Company careers pageValidated by: Fursa AI
Last checked: 18 hours agoStatus: Live

Job Summary

Lead cross-functional quality and regulatory processes in Colombia and LATAM, ensuring compliance with local and international requirements for medical devices and IVD. Own and continuously improve the QMS (ISO-based), manage regulatory submissions and documentation (registrations, updates, renewals), and ensure product traceability, storage, and distribution. Oversee quality reporting, adverse events, complaints, and market withdrawals, coordinating audits, certifications, and relationships with regulatory authorities.
Location: Bogotá
Workplace: Hybrid
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Manager level

Key Responsibilities

  • •Lead the implementation, maintenance, and continuous improvement of the QMS.
  • •Ensure compliance with local and international regulations for medical devices and IVD.
  • •Manage regulatory processes including registrations, modifications, renewals, and document management.
  • •Ensure product traceability, proper storage, and distribution.
  • •Manage quality reporting and post-market activities (adverse events, complaints, withdrawals) and coordinate audits/certifications with regulators.
Travel: High travel

Pay and Benefits

Salary: COP 1 monthly

Key Requirements

  • •Professional in Bacteriology or a health-related field.
  • •Desirable postgraduate degree in Quality or related areas.
  • •5–7 years of experience in Quality and/or Regulatory Affairs roles.
  • •Experience with Colombian healthcare regulation and medical devices.
  • •Intermediate to advanced English; knowledge of QMS (ISO 9001 and/or ISO 13485) and regulatory processes/compliance.
Experience:5-7 yearsMedical devicesIVDRegulatory affairsHealthcareISO compliance
Education:
Languages:English
Tech Stack:ISO 9001ISO 13485

Company Brief

Distro
Provides a SaaS platform to simplify app distribution and release management, helping developers and teams build, share, and deploy mobile and web app builds to testers and stores.
Industry: Developer Tools
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