Regulatory Affairs Engineering Lead, Clinical Evaluation
Neko Health · Stockholm
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- Company
- Neko Health
- Location
- Stockholm
- Employment type
- Full-time
- Posted
- September 21, 2026
About this job
ABOUT THE ROLE We're looking for a regulatory affairs engineer to own the clinical side of Neko's regulatory work. You'd write the clinical evaluation plans and reports, and the clinical documentation behind our submissions to the FDA, the EU and the UK. Neko generates its own clinical evidence, so this is authored work. You'd plan and support clinical studies and investigations under ISO 14155, appraise the literature and the clinical data behind each claim, and keep the clinical evaluation current as the devices change. It's hands-on and it runs across both hardware and software, working closely with the engineering, clinical and quality teams. You'd join a small regulatory team where the other engineers come from hardware and software backgrounds, which is why this role leans clinical.…
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