Regulatory and Quality Affairs Manager
Mölnlycke Health Care · São Paulo, São Paulo, Brazil
**At Mölnlycke, we believe real impact starts with people.** People who challenge the status quo. People driven by purpose. **People Who See Opportunities Where Others See Challenges.** People who believe that innovation, scientific knowledge, and collaboration can transform patient care. As a global leader in medical solutions, we develop innovative products and services across Wound Care, Operating Room Solutions, Gloves, and Antiseptics. Our purpose is to support healthcare professionals in achieving better clinical, economic, and patient outcomes while enabling more efficient, sustainable, and patient\-centered care. Behind every product that reaches the market is a rigorous regulatory and quality process. That is why our Quality Assurance \& Regulatory Affairs team plays a critical role in ensuring our solutions meet the highest global standards and the requirements of health authorities across Latin America. **The Opportunity** We are looking for a **Regulatory and Quality Affairs Manager (LATAM)** . This position goes far beyond regulatory and quality management. We are seeking a professional who can lead the regulatory and quality strategy across Latin American markets, ensuring compliance with local and global requirements, supporting growth initiatives, and acting as a strategic business partner. You will work closely with commercial teams, supply chain, operations, global functions, and health authorities, directly contributing to product availability, portfolio expansion, and the sustainable growth of Mölnlycke across the region. **How You Will Make a Difference** In this role, you will be responsible for leading Regulatory Affairs and Quality Assurance activities across LATAM markets, ensuring regulatory compliance, quality excellence, and strategic business support. Your key responsibilities will include: * 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 Mölnlycke 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. **What We Offer** At Mölnlycke, you will find an environment where trust, autonomy, and collaboration are part of our culture. We offer: * 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. **Required Qualifications** **What We Are Looking For** * 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 (C