Example Company
Software engineer
- Location
- San Francisco
- Type
- Full time
- Compensation
- $150k-$200k
- Posted
- 2 days ago
Join a team building useful software. Work closely with engineering and design to turn new ideas into products.
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Regulatory Affairs Intern
- Location
- São Paulo
- Type
- PartTime
- Posted
- 7D AGO
About the role
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, apply now!
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