Regulatory and Quality Analyst

Molnlycke Health Care; São Paulo; Presencial; BRL 100 000 - 167 000; Tempo integral

Resumo da oferta

Mölnlycke, a global medical solutions company, seeks a QARA Analyst for its São Paulo team to strengthen quality and regulatory operations across Latin America.

The role includes executing RQA activities, handling complaints in the eQMS, supporting regulatory submissions, and ensuring compliance across product licenses. Fluency in English and Spanish is required, with a co-technical responsibility registration essential.

Qualificações

• Bachelor's degree in Health Sciences.
• Active registration with the relevant professional body to act as co-technical responsible.
• 1 to 3 years of experience in Quality Assurance and/or Regulatory Affairs within a Medical Devices company.
• Knowledge of Medical Device regulations, including ANVISA and other Latin American health authorities.
• Advanced English proficiency (minimum C1 level).
• Advanced Spanish proficiency.

Responsabilidades

• Executing and maintaining RQA activities, processes, and files.
• Receiving and recording complaints in the eQMS.
• Supporting regulatory submission activities to obtain and maintain product licenses throughout Latin America.
• Providing regulatory support for assigned projects and marketing initiatives.
• Executing regulatory filings for new product introductions, license renewals, and product or license changes.
• Reviewing regulatory documents and labeling to support compliance with applicable regulations.
• Supporting internal audits and partner company qualification activities.
• Following up on requests from health authorities across the region and supporting compliance with regulatory requirements.

Conhecimentos

Quality Assurance

Regulatory Affairs

Attention to detail

Multitasking

Formação académica

Bachelor's degree in Health Sciences

Descrição da oferta de emprego

At Mölnlycke, we believe that meaningful impact starts with people.

People who are driven by purpose.
People who embrace responsibility and continuous improvement.
People who collaborate across functions and geographies to support better healthcare outcomes.
People who understand that every detail matters when quality, compliance, and patient safety are at stake.

As a global medical solutions company, we develop and supply innovative products and services within wound care, operating room solutions, gloves, and antiseptics. Our purpose is to advance healthcare performance by supporting healthcare professionals and improving outcomes where they matter most.

Within Mölnlycke, quality and regulatory excellence are fundamental to ensuring that our products meet the highest standards and remain available to healthcare professionals and patients across Latin America.

Mölnlycke is now looking for a QARA Analyst to join our team in São Paulo.

Why this role matters

This is more than a job opportunity. It is a chance to contribute directly to quality assurance and regulatory activities that support product compliance, patient safety, and business continuity across Latin America.

As a QARA Analyst, you will play an important role in maintaining quality and regulatory processes while collaborating closely with Supply Chain, Regulatory Affairs, and external partners.

Your key contributions will include:

• Executing and maintaining RQA activities, processes, and files.
• Receiving and recording complaints in the eQMS.
• Supporting critical quality activities, including stock blocking and product traceability.
• Supporting regulatory submission activities to obtain and maintain product licenses throughout Latin America.
• Providing regulatory support for assigned projects and marketing initiatives.
• Executing regulatory filings for new product introductions, license renewals, and product or license changes.
• Reviewing regulatory documents and labeling to support compliance with applicable regulations.
• Supporting internal audits and partner company qualification activities.
• Following up on requests from health authorities across the region and supporting compliance with regulatory requirements.

What we offer

Join a company where quality, collaboration, accountability, and continuous learning are valued every day.

Your growth and development

You will have the opportunity to build experience across quality assurance and regulatory affairs in a dynamic, international healthcare environment.

• Exposure to quality and regulatory activities across Latin America.
• Collaboration with cross-functional teams, including Supply Chain and Regulatory Affairs.
• Participation in audits, partner qualification processes, and regulatory submissions.
• Opportunities to contribute to projects supporting product introductions and lifecycle management.
• A collaborative environment focused on learning and professional development.

Work environment

• Monthly visits to Logistics Operator facilities.
• Occasional overnight travel is required.

What we're looking for

Required qualifications and experience

• Bachelor's degree in Health Sciences.
• Active registration with the relevant professional body to act as co-technical responsible.
• 1 to 3 years of experience in Quality Assurance and/or Regulatory Affairs within a Medical Devices company.
• Knowledge of Medical Device regulations, including ANVISA and other Latin American health authorities.
• Advanced English proficiency (minimum C1 level).
• Advanced Spanish proficiency.
• Strong attention to detail and ability to manage multiple tasks simultaneously.

Diversity & Inclusion

At Mölnlycke, we are committed to creating an environment where everyone feels respected, valued, and empowered to contribute. We believe that diverse perspectives strengthen our teams, broaden our thinking, and help us create better solutions for healthcare professionals and patients around the world.

Inclusion is not only a principle for us. It is embedded in how we collaborate, innovate, and succeed together.

Mölnlycke is a world-leading medical solutions company dedicated to helping healthcare professionals achieve the best possible patient, clinical, and economic outcomes.

Our business is organized into four core areas: Wound Care, Operating Room Solutions, Gloves, and Antiseptics. Across all areas, we place customers, sustainability, and digitalization at the center of everything we do.

With approximately 8,700 employees worldwide, Mölnlycke is headquartered in Gothenburg, Sweden, and operates in more than 100 countries.

Job Posting Location: Brazil Sales Office