Quality Assurance and Regulatory Affairs Specialist Department: Operations Employment Type: Full Time Location: LATAM-Colombia-Bogota Description Quality Assurance and Regulatory Affairs Specialist Description 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. Key Responsibilities Responsabilities: Quality Assurance Support the implementation of the local Quality Management System in Colombia. Ensures that local regulatory requirements and Global Align policies that impact the Quality System are appropriately addressed by relevant QMS procedures. Support QMS activities: management reviews, internal/suppliers audit, QMS process training, and CAPA activities. Collaborate with the 3PL to ensure regulatory compliance of the operation during the importation, storage, and distribution activities. Ensure good distribution and documentation practices are followed. Regulatory Affairs Collaborate with cross-functional teams to ensure regulatory compliance across all operations. Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements. Responsible for market clearance or product registration approval, renewals and amendments. Support with the regulatory post-market obligations, including complaint reporting, nonconformity management, and recalls, are adequately documented and addressed on time. Complimentary skills 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. Skills, Knowledge & Expertise Requirements : 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. #J-18808-Ljbffr