Job Title: Quality Assurance and Regulatory Affairs Specialist \ The Quality Assurance and Regulatory Affairs Specialist will be responsible for supporting local Quality and Regulatory strategies, including local QMS and regulatory compliance in Colombia. This position requires in-depth and broad knowledge of Colombian regulation applicable to Medical Devices, critical thinking, and collaboration skills. \ This role involves implementing the local Quality Management System in Colombia, ensuring that local regulatory requirements and Global Align policies that impact the Quality System are appropriately addressed by relevant QMS procedures. Additionally, it entails supporting QMS activities such as management reviews, internal/suppliers audit, QMS process training, and CAPA activities. \ Another key responsibility is collaborating with cross-functional teams to ensure regulatory compliance across all operations. This includes maintaining Regulatory affairs documentation to support compliance with applicable regulatory requirements. \ Responsibilities include: \ \ - Supporting the implementation of the local Quality Management System in Colombia. \ - Ensuring that local regulatory requirements and Global Align policies that impact the Quality System are appropriately addressed by relevant QMS procedures. \ - Supporting QMS activities such as management reviews, internal/suppliers audit, QMS process training, and CAPA activities. \ - Collaborating with cross-functional teams to ensure regulatory compliance across all operations. \ - Maintaining Regulatory affairs documentation to support compliance with applicable regulatory requirements. \ - Responsible for market clearance or product registration approval, renewals and amendments. \ - Supporting with the regulatory post-market obligations, including complaint reporting, nonconformity management, and recalls, are adequately documented and addressed on time. \ - Attention to detail. \ - Excellent organizational skills. \ - Strong critical thinking and problem-solving abilities. \ - Proficiency in managing multiple tasks and prioritizing effectively. \ - Independence and self-direction, with a strong desire to work collaboratively as part of a high-performing team. \ - Minimum of 4 years in Quality Assurance and Regulatory Affairs role with Medical Devices; Desirable experience with Custom-made Medical Devices (dental supplies). \ - Deep knowledge of Colombian regulatory requirements for medical devices, including product registration and import requirements. Desirable experience in CCAA requests or receiving INVIMA inspections. \ - Bachelor's degree in Pharmacy, Biomedical Engineering, or similar. Mandatory be graduate (Tarjeta Profesional) \ - Advanced Microsoft Office skills, including Word, PowerPoint, and Visio \ - Advanced English. \