Regulatory Affairs Engineer

il y a 4 semaines


Paris, Île-de-France Eko Devices Temps plein

We are seeking a skilled Senior Frontend Engineer to join our dynamic team at Eko Devices. As a Senior Frontend Engineer, you will play a crucial role in ensuring that our medical devices are developed, manufactured, and maintained in compliance with relevant regulations and standards. Our team is distributed across Europe, and we have a flexible workplace that focuses on productivity and collaboration. We are committed to work/life balance and believe in our mission without sacrificing everything else. The ideal candidate will have extensive experience with regulatory submissions for different international markets, a background in medical device development in general and agile software development in particular, and effective communication skills (written and verbal) and teamwork abilities, essential for our remote-first environment. The Senior Frontend Engineer will be responsible for developing and maintaining regulatory documentation, including Design History File (DHF), Technical Documentation, and Risk Management Files, as well as staying current with changes in global regulatory requirements and communicating these changes to relevant stakeholders. If you are a skilled Senior Frontend Engineer looking for a new challenge, please apply.



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