Regulatory and Quality Affairs Manager

Molnlycke Health Care; São Paulo; Híbrido; BRL 300 000 - 600 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work model (São Paulo)

Annual incentive program

30 days vacation

13th salary

Resumo da oferta

Mölnlycke seeks a Regulatory and Quality Affairs Manager (LATAM) to lead regulatory strategy and quality assurance across Latin American markets from its São Paulo base. You will work with commercial, supply chain, and health authorities to ensure timely registrations and continuous compliance.

In this hybrid São Paulo role, you will act as Technical Responsible Person in Brazil and guide regional initiatives, audits, and regulatory inspections. english/spanish fluency required.

Qualificações

• Bachelor’s degree in Health Sciences or related field (required).
• Advanced English (C1) and Spanish (C1) are required.
• Experience in Regulatory Affairs and Quality Assurance in medical devices.

Responsabilidades

• Define and execute regulatory strategies for LATAM markets.
• Ensure compliance with health authorities and regulations.
• Act as Technical Responsible Person in Brazil.
• Lead interactions with regulatory authorities and partners.
• Prepare regulatory dossiers for LATAM and U.S. markets.
• Maintain Quality Management System across operations.
• Support regulatory inspections and audits.
• Manage budgets and resources for QA/RA.

Conhecimentos

English proficiency

Spanish proficiency

Analytical thinking

Communication skills

Multitasking

Organizational skills

Formação académica

Bachelor’s degree in Health Sciences or related field

Ferramentas

eCTD submissions

Descrição da oferta de emprego

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, supplychain, 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.
• Annual incentive program.
• 30 days of paid vacation.
• 13th salary payment.

What We Are Looking For

Required Qualifications

• 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.

Preferred Qualifications

• 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.

Who Will Succeed in This Role

You will thrive in this position if you combine strategic vision, regulatory expertise, and the ability to influence a wide range of stakeholders.

We are looking for someone who is highly organized, committed to quality and compliance, and capable of balancing regulatory excellence with business needs.

The ideal candidate will bring strong leadership capabilities, analytical thinking, the ability to navigate complex environments, and a passion for ensuring innovative healthcare solutions reach patients safely and in full regulatory compliance.

Diversity & Inclusion

At Mölnlycke, we believe that diverse perspectives drive innovation.

We are committed to creating an environment where everyone feels respected, valued, and empowered to reach their full potential.

Diversity, equity, and inclusion are integral to how we work, innovate, and shape the future of healthcare.

Mölnlycke is a world-leading medical solutions company dedicated to improving clinical, economic, and patient outcomes.

Our business is organized around four core areas: Wound Care, Operating Room Solutions, Gloves, and Antiseptics, always with a focus on innovation, sustainability, and customer experience.

We operate in more than 100 countries, employ approximately 8,700 people, and are headquartered in Gothenburg, Sweden.

Since 2007, we have been part of Investor AB, one of Sweden’s most established investment companies, founded by the Wallenberg family in 1916.

Job Posting Location: Brazil Sales Office