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Neko Health is a preventative healthcare company that combines proprietary technology with clinical care to deliver personalized health insights in a single non-invasive visit. The company designs and manufactures its own medical devices.
You will work at the critical juncture where finished designs transition into manufacturing. Your responsibilities span design transfer, regulatory compliance, and manufacturing lifecycle management. Day-to-day work includes:
- Managing design transfer from engineering to production, ensuring good manufacturing practice (GMP) compliance throughout the process
- Applying and maintaining regulatory requirements for incoming component controls and supplier quality
- Overseeing calibration and maintenance of manufacturing equipment per regulatory standards
- Managing manufacturing records and device release documentation
- Preparing shipment documentation for international markets, particularly FDA documentation for US exports, including customs paperwork for each shipment
- Coordinating with production teams to ensure regulatory declarations align with actual manufacturing
- Monitoring GMP compliance across all manufactured devices and addressing gaps
- Working on-site with production and manufacturing teams daily
- Contributing to product-related regulatory activities involving manufacturing and distribution
This role offers direct visibility into both design decisions and their manufacturing outcomes. You will be the person the company relies on for regulatory compliance and market release, with a short feedback loop between engineering and production. You will report to an experienced RA Engineering Lead who provides guidance and supports regulatory judgment calls.
The role may be hired as either a Regulatory Affairs Engineer (Mid Level) or an RA Engineering Lead (Manager) depending on experience.
REQUIREMENTS:
- BSc or MSc in engineering, relevant scientific or technical discipline, or equivalent professional experience
- 3–5 years of experience in quality or regulatory affairs for medical devices, with direct manufacturing exposure (either quality or regulatory background acceptable, but strong understanding of device manufacturing regulatory requirements is essential)
- Working knowledge of ISO 13485, EU Regulation 2017/745 (MDR), and FDA 21 CFR Part 820, with particular emphasis on production/process control and device release requirements
- Familiarity with documentation required for exporting medical devices, including FDA import requirements and customs documentation
- Experience supporting design transfer or production process validation
- Fluent in English (oral and written); Swedish knowledge is a plus
- Comfortable using AI tools such as Claude for research, drafting, and operational efficiency
- Experience with Visual Studio Code and Azure DevOps is a plus
