Neko Health AB seeks a regulatory affairs engineer to own the clinical regulatory work for our devices, drafting clinical evaluation plans and reports and supporting submissions to the FDA, EU and UK.
The role spans hardware and software, collaborating with engineering, clinical and quality teams, and emphasizes ISO 14155, IEC standards, and post-market surveillance throughout product development.
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Regulatory Affairs Engineer — Clinical Evidence Lead employer: Neko Health AB
At Neko, we are committed to fostering a culture of innovation and collaboration, where every team member plays a vital role in transforming healthcare through technology. As a Lead Software Engineer, you will not only have the opportunity to work on cutting-edge AI-driven solutions but also engage directly with clinicians and members, ensuring your contributions make a real impact on people's health. With a focus on employee growth and a supportive environment, Neko offers a unique chance to be part of a mission that prioritises preventative care and enhances the well-being of communities.
