Quality Analyst

Description

Job Summary: Opportunity for a Lawyer at a health technology company to lead certification, registration, and compliance of products, as well as implement the ISO 13485 QMS. Key Highlights: 1. Leadership in certification and regulatory compliance of health products. 2. Quality Management System (QMS) ISO 13485 management. 3. Work in a health technology environment with national and international impact. Opportunity for a Lawyer at a health technology company. We are seeking a Quality Analyst to lead our product certification, registration, and compliance activities with major national regulatory agencies (ANVISA, ANATEL, INMETRO) and international agencies (e.g., FDA and European authorities). This professional will also be responsible for implementing and managing a Quality Management System (QMS) based on ISO 13485\. **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, among others;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 stages of the product lifecycle;Collaborate with R\&D, Engineering, Production, Legal, and Commercial teams to ensure regulatory compliance from product conception through to commercialization. **Technical Requirements:** Bachelor's degree in Pharmacy, Biomedical Engineering, Biomedicine, or related fields.Postgraduate qualification or certification in Quality and Regulatory Affairs (preferred).Proven experience in Quality and Regulatory Affairs, including documented 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 task execution while maintaining work quality.Ability to analyze scenarios and decisively select optimal solutions.Ease of collaboration and interaction with professionals from diverse backgrounds. **Minimum Education Level:** High School (Secondary Education)