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<p>Quality Assurance and Regulatory Affairs Specialist</p> <p>Description</p> <p>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.</p> <p>Responsabilities:</p> <p>Quality Assurance</p> <ul> <li>Support the implementation of the local Quality Management System in Colombia. </li><li>Ensures that local regulatory requirements and Global Align policies that impact the Quality System are appropriately addressed by relevant QMS procedures. </li><li>Support QMS activities: management reviews, internal/suppliers audit, QMS process training, and CAPA activities. </li><li>Collaborate with the 3PL to ensure regulatory compliance of the operation during the importation, storage, and distribution activities. </li><li>Ensure good distribution and documentation practices are followed. </li></ul> <p>Regulatory Affairs</p> <ul> <li>Collaborate with cross-functional teams to ensure regulatory compliance across all operations. </li><li>Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements. </li><li>Responsible for market clearance or product registration approval, renewals and amendments. </li><li>Support with the regulatory post-market obligations, including complaint reporting, nonconformity management, and recalls, are adequately documented and addressed on time. </li></ul> <p>Complimentary skills</p> <ul> <li>Attention to detail. </li><li>Excellent organizational skills. </li><li>Strong critical thinking and problem-solving abilities. </li><li>Proficiency in managing multiple tasks and prioritizing effectively. </li><li>Independence and self-direction, with a strong desire to work collaboratively as part of a high-performing team. </li></ul>
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