Regulatory Affairs & Technovigilance Specialist

About the role

QHA is looking for a Regulatory Affairs & Technovigilance Specialist to lead the regulatory compliance of medical devices in Guatemala and El Salvador. The role bridges commercial activities with health regulations, ensuring product registrations, post‑market surveillance, and technical documentation are maintained.

Key responsibilities

• Lead the complete process of obtaining and renewing sanitary registrations for new and existing medical devices in Guatemala and El Salvador.
• Maintain rigorous control of licenses, ISO certifications, and representation letters, updating tracking tools in real time.
• Communicate directly with health authorities (MSPAS, DNM/SRS), suppliers, and pharmaceutical representatives.
• Coordinate the local technovigilance system, report adverse events, and manage corrective and preventive actions (CAPA).
• Prepare and submit required reports to regulatory bodies.
• Manage technical documentation for hospital‑delivered equipment and ensure traceability of service reports.
• Organize internal training on proper handling of medical supplies and equipment.

Required profile

• Bachelor’s degree in Pharmaceutical Chemistry, Biomedical Engineering, Health Administration or related field.
• 2–3 years of experience in medical device regulatory registration in Guatemala and/or El Salvador.
• Strong analytical mindset, attention to detail, and excellent interpersonal communication.

Required skills

• Knowledge of technovigilance regulations and post‑commercialization risk management.
• Familiarity with ISO 13485 and ISO 9001 standards.
• Regulatory affairs expertise for medical devices.