Regulatory Affairs & Quality Manager

About the Role

We are looking for a QA & RA Manager to lead and manage transversal Quality and Regulatory Affairs processes in Colombia and LATAM, ensuring regulatory compliance, the implementation of the quality management system, and regulatory control with health authorities.

Job Responsibilities

• Lead the implementation, maintenance, and improvement of the quality management system (QMS).
• Ensure compliance with local and international regulations for medical devices and IVDs.
• Supervise regulatory processes: registrations, modifications, renewals, and document management.
• Ensure traceability, storage, and adequate distribution of products.
• Manage quality reports, adverse events, complaints, and product recalls from the market.
• Coordinate audits, certifications, and relationships with regulatory entities.

Required Skills & Experience

• Education: Professional in Bacteriology or health-related fields. Postgraduate degree in Quality or related areas is desirable.
• Experience: 5 to 7 years in Quality and/or Regulatory Affairs roles. Experience in Colombian health regulations and medical devices.
• Languages: Intermediate / advanced English.
• Knowledge:
  • Quality management systems (ISO 9001 and/or ISO 13485).
  • Regulatory processes, sanitary registrations, and compliance.

What Else Should You Know

• Availability for national and international travel.
• Hybrid modality.

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