Quality Analyst

Description

Job Summary: Opportunity for a Lawyer at a health technology company, serving as a Quality Analyst to lead certifications, registrations, and regulatory compliance of products. Key Highlights: 1. Lead medical device certifications and registrations (ANVISA, FDA, CE). 2. Implement and manage a Quality Management System (QMS) based on ISO 13485. 3. Collaborate with R&D, Engineering, Legal, and Commercial teams. Opportunity for a Lawyer at a health technology company. We seek a Quality Analyst to lead certification, registration, and regulatory compliance activities for our products with major national regulatory agencies (ANVISA, ANATEL, INMETRO) and international authorities (e.g., FDA and European regulatory bodies). This professional will also be responsible for implementing and managing a Quality Management System (QMS) based on the ISO 13485 standard. **Key Responsibilities:** Coordinate medical device certification and registration processes with ANVISA, ANATEL, and INMETRO;Prepare the company and its products for export, including international certifications such as FDA (USA) and CE marking (Europe);Plan, implement, and maintain the Quality Management System (QMS) in accordance with ISO 13485 requirements and other applicable standards;Draft, review, and approve quality documents, such as SOPs, work instructions, validation plans, etc.;Conduct internal audits and serve as the focal point during external and regulatory audits;Manage non-conformities, corrective and preventive actions (CAPAs), change control, and continuous improvement processes;Promote a quality culture and ensure regulatory compliance across all product lifecycle stages;Collaborate with R\&D, Engineering, Manufacturing, Legal, and Commercial teams to ensure regulatory compliance from product conception through commercialization. **Technical Requirements:** Bachelor's degree in Pharmacy, Biomedical Engineering, Biomedicine, or related fields. Postgraduate studies or certification in Quality and Regulatory Affairs (preferred). Proven experience in Quality and Regulatory Affairs, including medical device registration and certification with ANVISA, ANATEL, and INMETRO, and implementation and maintenance of an ISO 13485-based QMS. Advanced knowledge of national and international regulatory frameworks (e.g., ANVISA, INMETRO, FDA, EMA, ISO, QSR). Advanced English (reading, writing, and speaking). **Behavioral Profile:** Ability to efficiently manage tasks and priorities. Skill to communicate clearly and concisely across various channels. Speed and efficiency in executing tasks while maintaining work quality. Aptitude to analyze scenarios and decisively select optimal solutions. Ease of collaboration and interaction with professionals of diverse backgrounds. **Minimum Education Level:** High School (Secondary Education)