Neko Health
Regulatory Affairs Engineer, Manufacturing Lifecycle
Stockholm, Remote. Posted a month ago
The role
This person will work on design transfer and regulatory compliance for manufacturing and distribution. They will manage the transition of products from engineering to production and handle documentation for device release and shipments.
What you will do
- Turn the handover from engineering into production into a controlled process.
- Apply and maintain regulatory requirements for incoming component controls.
- Apply and maintain regulatory requirements for equipment calibration and maintenance.
- Manage manufacturing records and device release records.
- Prepare documentation for shipments to other markets, including US customs and FDA documentation.
- Coordinate shipments with production.
- Monitor good manufacturing practice and follow up on gaps.
- Work day-to-day with production and manufacturing teams on site.
- Contribute to product-related regulatory activities involving manufacturing and distribution.
Required qualifications
- BSc or MSc in engineering, a relevant scientific or technical discipline, or equivalent professional experience.
- Three to five years of experience in quality or regulatory affairs for medical devices, with direct exposure to manufacturing.
- Working knowledge of ISO 13485, EU Regulation 2017/745 (MDR), and FDA 21 CFR Part 820.
- Familiarity with documentation for exporting medical devices, including FDA import requirements and customs documentation.
- Experience in supporting design transfer or production process validation.
- Fluent in English (oral and written).
- Comfortable using AI tools, such as Claude, for research, drafting, and enhancing operational efficiency.
Nice to have
- Knowledge of Swedish is a plus.
- Experience with Visual Studio Code and Azure DevOps is a plus.
Benefits
- Competitive salary and benefits package.
About the company
Neko is redefining prevention by making data-driven, preventative care accessible. The company designs and manufactures its own devices to deliver personalised, actionable insights.