Regulatory Affairs Intern – LATAM

About the role

ResMed's RA Global team supports compliance with regulatory frameworks for the design, development and manufacture of products and services. As a Regulatory Affairs intern based in São Paulo, Brazil (with remote flexibility), you will support the LATAM Regional RA team with routine product submissions to obtain regulatory market access for medical and non-medical software and systems across Latin America. You work within the strategies set by the Regional RA team and collaborate with Global Product Development, Marketing, Regulatory and Commercial teams.

Key responsibilities

• Support pipeline demand and execute strategies for target devices and channels, working with regional RA, product development, clinical, marketing, distributors and commercial functions.
• Help prepare and compile submission documents for premarket registrations in Latin America and support post-market regulatory compliance of existing ResMed products, including software as a medical device.
• Track and maintain regulatory records, including archiving submission documentation and expense records.
• Communicate proactively with internal stakeholders, external parties and regulatory consultants so applications reach local health authorities and approvals are obtained efficiently.
• Assist with impact assessments of new or updated regulations and external standards.
• Keep up to date with regulatory topics such as LATAM country-specific regulations, medical device policies, global registration and technical writing.

Required profile

• Currently enrolled in a Bachelor's-level university programme in Life Sciences or Engineering; 3rd or 4th year students preferred.
• Strong English communication skills are mandatory; Portuguese as a native language.
• Creative, detail-oriented, resourceful, highly organised and able to follow up with internal and external stakeholders independently.

Required skills

• Working knowledge of Microsoft Office tools.