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Regulatory Affairs & Quality Manager

1 month, 1 week ago
Colombia, Latin America
Full-time
Senior
Operations Manager
Quality Assurance and Testing
Apply Now
Distro

Distro

DISTRO is a global platform for companies to interview and hire candidates for full-time roles efficiently.

Internet Software & Services
11-50
View All Jobs 16

Description

  • Lead the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
  • Ensure compliance with local and international regulations for medical devices and IVDs.
  • Oversee regulatory processes including registrations, amendments, renewals, and document management.
  • Ensure proper traceability, storage, and distribution of products.
  • Manage quality reports, adverse events, complaints, and product recalls.
  • Coordinate audits, certifications, and interactions with regulatory authorities.
  • Support compliance and regulatory control across Colombia and LATAM operations.

Requirements

  • Professional degree in Bacteriology or a health-related field.
  • Preferred postgraduate studies in Quality or related areas.
  • 5 to 7 years of experience in Quality and/or Regulatory Affairs roles.
  • Experience with Colombian health regulations and medical devices.
  • Intermediate to advanced English proficiency.
  • Knowledge of quality management systems such as ISO 9001 and/or ISO 13485.
  • Knowledge of regulatory processes, sanitary registrations, and compliance.
  • Availability for national and international travel.
  • Hybrid work modality available.
  • Experience in medical devices and IVD regulation is required.

Interested in this position?

Apply directly on the company website

Apply Now

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