Regulatory Affairs Intern

Medifox DAN GmbH; São Paulo; Híbrido; BRL 20 000 - 31 000; Tempo parcial

Resumo da oferta

Medifox DAN GmbH, based in Brazil (São Paulo area) with remote flexibility, seeks a student for LATAM Regulatory Affairs support. You will assist with premarket submissions for Latin America and help maintain post-market compliance for medical and software-enabled devices.

You will collaborate with regional RA, product development, clinical, marketing, and commercial teams to support regulatory strategies and timely submissions, while learning LATAM country-specific regulations and global

Qualificações

• Currently enrolled in a university degree program (Bachelor’s level) in Life Sciences or Engineering; 3rd or 4th year preferred.
• Strong interpersonal communication skills in English are mandatory; Portuguese as a native language.
• Working knowledge of Microsoft Office tools.

Responsabilidades

• 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 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 internal stakeholders to ensure transparency of the regulatory strategies and status updates; external stakeholders to ensure applications are submitted to local health authorities; and regulatory consultants to ensure adequate information is provided to drive submissions to approval.
• Assist the internal workflow for impact assessments on new or updated regulations and external standards.

Conhecimentos

English proficiency

Portuguese native

Formação académica

Bachelor’s degree candidate in Life Sciences or Engineering

Ferramentas

MS Office

Descrição da oferta de emprego

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. If this sounds like the workplace for you,