Quality Assurance and Regulatory Affairs Specialist Join to apply for the Quality Assurance and Regulatory Affairs Specialist role at Align Technology Quality Assurance and Regulatory Affairs Specialist Join to apply for the Quality Assurance and Regulatory Affairs Specialist role at Align Technology Description Quality Assurance and Regulatory Affairs Specialist Description Department: Operations 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. Responsabilities: Key Responsibilities 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. Requirements : Skills, Knowledge & Expertise 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. Applicant Privacy Policy: Review our Applicant Privacy Policy for additional information. Equal Opportunity Statement: Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Quality Assurance Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Align Technology by 2x Get notified about new Quality Assurance Specialist jobs in Bogota, D.C., Capital District, Colombia . 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