Regulatory Affairs and Quality Intern

Cardiologs (Paris, France) Publié il y a 12 heures
At Cardiologs, our mission is to make tomorrow’s medical diagnosis efficient and accessible to everyone, anywhere, anytime. We leverage machine learning (AI) and cloud computing technologies to fulfill this vision. Our first product is a SaaS application to help physicians diagnose cardiac diseases, already deployed worldwide.

We are a tight-knit team and we nurture our company culture with monthly all-hands meetings and apéros, daily coffee breaks in our comfy kitchen... But most importantly, we believe that a good atmosphere at work makes people more efficient in what they are best at!

The solution Cardiologs was the first medical device using the deep-learning technology, to receive the CE mark in August 2016, and the second to be approved by the FDA in the United States in June 2017. Cardiologs is currently in the commercial development phase in Europe and the United States.

What you’ll do

In the RAQA (Regulatory Affairs and Quality Assurance) team, the intern will:
- Participate in the feasibility, action plan and implementation of MDSAP requirements
- Prepare for international registrations
- Participate in the update of the technical files of CE marking in conformity with the new regulation
- Participate in the drafting and review of documents relating to regular product modification
- Participate in the development and maintenance of the company's QMS procedures
- Participate in the implementation of an EDM system (electronic management system)
- Participate in quality assurance activities (e.g.,usability, software validation, supplier management).

Who you are

- A student in M1/M2 in Medical Devices 
- Knowledge of the medical device industry and interest in regulatory affairs & quality assurance
- Fluent in written English, and have at least basic notions in French
- Rigorous and organized
- Autonomous
- Good interpersonal skills

Our Recruiting Process
Being authorised to work in the EU is a precondition of employment.

- Quick introductory HR phone call
- Technical and Performance Interview in our office or by Zoom
- Culture interview in our office or by Zoom

Start Date : March 2021
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Regulatory Affairs and Quality Intern

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