Regulatory and quality affairs manager – São Paulo/SP

Responsabilidades

• Define and execute regulatory strategies for new product introductions, license renewals, and regulatory changes across Latin American markets.
• Ensure compliance with health authorities and all applicable regulations within assigned countries.
• Act as the Technical Responsible Person for empresa operations in Brazil.
• Represent Quality and Regulatory Affairs within the LATAM Leadership Team, providing impact assessments and strategic support for regional initiatives.
• Ensure product registrations, licenses, and regulatory approvals are in place before commercial distribution.
• Manage interactions and responses with regulatory authorities, either directly or through local partners.
• Monitor regulatory changes and assess their impact on the business.
• Collaborate with global and regional teams to ensure local regulatory requirements are understood and incorporated into business plans.
• Prepare, compile, submit, and maintain regulatory dossiers for LATAM and U.S. markets.
• Assess regulatory impacts associated with manufacturing, formulation, labeling, and quality changes.
• Ensure implementation and maintenance of Quality Management System requirements.
• Oversee the quality performance of logistics providers, distributors, warehousing, and transportation partners.
• Plan and support regulatory inspections, GMP audits, and quality audits.
• Support global Field Safety Corrective Action (FSCA) processes, including local impact assessments and execution when required.
• Ensure critical quality processes such as traceability and product blocking are properly implemented and maintained.
• Manage departmental budgets and resources for Quality and Regulatory Affairs activities.

Requisitos

• QUALIFICAÇÕES MÍNIMAS
  • Bachelor’s degree in Health Sciences or a related field.
  • Active professional registration allowing you to act as Technical Responsible Person in Brazil.
  • Solid experience in Regulatory Affairs and Quality Assurance within the medical device industry.
  • Strong knowledge of medical device regulations, including ANVISA requirements and other Latin American health authorities.
  • Experience with quality systems, regulatory compliance, and risk management.
  • Advanced English proficiency (C1).
  • Advanced Spanish proficiency (C1).
  • Strong analytical and critical thinking skills.
  • Excellent written and verbal communication skills.
  • Ability to manage multiple priorities in a dynamic environment.
  • Strong organizational skills and exceptional attention to detail.
• QUALIFICAÇÕES PREFERENCIAIS
  • Experience leading Regulatory Affairs and Quality teams in multicultural environments.
  • Knowledge of U.S. pharmaceutical regulatory requirements and FDA regulations.
  • Experience with electronic regulatory submissions (eCTD).
  • Experience supporting internal audits, external audits, and regulatory inspections.
  • Experience working with distributors, logistics operators, and third-party partners across Latin America.
  • Participation in global quality, compliance, or portfolio expansion projects.

Benefícios

• A culture built on trust, respect, and belonging.
• A collaborative environment where knowledge, innovation, and development go hand in hand.
• Real opportunities for professional growth and career development.
• Active participation in strategic initiatives that directly impact the LATAM business.
• Exposure to global teams and involvement in international projects.
• A highly visible position with direct influence on regulatory compliance, quality excellence, and regional growth strategies.
• A hybrid working model based in São Paulo.
• Permanent employment contract.
• Competitive salary.
• Annual incentive program.
• 30 days of paid vacation.
• 13th salary payment.
• Comprehensive benefits package.

Marcado como: ANVISA, Assuntos Regulatórios, Compliance, Controle de Qualidade, Produtos Médico-Hospitalares, Registro de Produtos