Neko Health AB seeks a regulatory affairs engineer to own the clinical side of regulatory work. You will author clinical evaluation plans and reports, and manage submissions to FDA, EU and UK, drawing on the company’s own clinical evidence.
You’ll plan and support clinical studies under ISO 14155, appraise literature and clinical data, and keep evaluations current as devices evolve, collaborating with hardware and software teams.
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Regulatory Engineering Lead, Medical Devices & Clinical Eval 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.
