Regulatory Affairs Intern

ResMed; São Paulo; Remote; BRL 20,000 - 27,000; Full time

Job summary

ResMed's Regulatory Affairs Global team in the São Paulo area, Brazil, offers a remote-flexible internship to support LATAM regulatory submissions for medical and non-medical software and systems. You will collaborate with regional RA, product development, clinical, marketing, distributors and commercial teams to help compile and file submissions and track records.

You will assist with premarket registrations for Latin America and maintain submission documentation, while staying informed about

Qualifications

• Currently enrolled in a university degree program (Bachelor’s level) and in 3rd or 4th year preferred.
• Strong English communication; Portuguese native language.
• Proficient with Microsoft Office and capable of working with cross-functional teams.

Responsibilities

• Support LATAM regulatory submissions and compliance activities under Regional RA guidance.
• Assist with preparation of submission documents for premarket registrations for Latin America, including software as a medical device.
• Track regulatory records and maintain submission documentation and expenses.
• Communicate with internal stakeholders and external authorities to ensure timely submissions.
• Collaborate with Global Product Development, Marketing, Regulatory and Commercial teams.
• Stay updated on LATAM regulations and regulatory topics.

Skills

English communication

Portuguese (native)

Interpersonal skills

Education

Bachelor's degree candidate in Life Sciences or Engineering

Tools

Microsoft Office

Job description

Let’s Talk About The Team And You

The RA Global team is located at various offices around the world and is responsible for compliance with multiple regulatory frameworks as it relates to design, development, and manufacture of products as well as services which meet our customer’s requirements.

Based in Brazil, São Paulo area, (with remote flexibility), you will be responsible for supporting the LATAM Regional RA team with routine, product submissions to obtaining regulatory market access for our innovative products, including medical and non-medical software and systems, across the LATAM region. This is achieved by performing your activities in alignment with the instructions and regulatory strategies defined by your peers in the Regional RA team for agency submission, and you will collaborate closely with Global Product Development, Marketing, Regulatory and Commercial teams.

Let’s talk about Responsibilities

• Work closely with regional RA, product development, clinical, marketing, distributors and commercial functions to support pipeline demand and execute the defined strategies for the target devices and channels.


• Assist with the preparation and compilation of submission documents for premarket registrations for Latin America, as well as continuance of regulatory compliance (particularly post market) of existing Resmed products, including software as a medical device.


• Track and maintain general regulatory records, including archiving of submission documentation, and expense records.


• Ensure timely, professional, and proactive communications with: (1) internal stakeholders to ensure transparency of the regulatory strategies and status updates; (2) external stakeholders to ensure applications are submitted to local health authorities consistent with regulatory strategic plan; and (3) regulatory consultants to ensure adequate and appropriate information is provided to drive submissions to approval as effectively as possible.


• Assist the internal workflow for impact assessments on new or updated regulations and external standards.


• Demonstrate continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including LATAM country specific regulations, and policies applying to medical devices, global registration, technical writing, etc.

Let’s talk about Qualifications and Experience

Required:

• Currently enrolled in a university degree program (Bachelor’s degree level) in a Life Sciences or Engineering related discipline, 3rd or 4th year students are preferred.


• Strong interpersonal communication skills in English are mandatory. Portuguese as a native language.


• Working knowledge of Microsoft Office tools.


• Creative, detail oriented, resourceful, highly organized, and able to keep track and follow up with internal and external stakeholders independently.

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates.