Regulatory Affairs Engineer, Manufacturing Lifecycle
Hybrid (Stockholm)Full-timePosted 4w ago
About the role
Regulatory Affairs Engineer responsible for design transfer and regulatory compliance of manufacturing and distribution of medical devices at Neko. Work is hands-on on the factory floor, partnering with production to ensure GMP, device release, and regulatory documentation for shipments (notably to the US). Reports to the RA Engineering Lead; role may be hired as Regulatory Affairs Engineer or RA Engineering Lead depending on experience.
Responsibilities
- Help turn the handover from engineering into production into a controlled process that satisfies good manufacturing practice requirements (design transfer).
- Apply and maintain the regulatory requirements for the controls on components entering the manufacturing facility.
- Apply and maintain the regulatory requirements for calibration and maintenance of manufacturing equipment.
- Look after the manufacturing records created when a device is built, and the records required to release it.
- Prepare, and be accountable for, the documentation for shipments to other markets, particularly the US, including customs documentation and accompanying FDA documentation, prepared for each individual shipment.
- Coordinate each shipment with production, ensuring that what Neko declares to the FDA is prepared by regulatory affairs.
- Monitor good manufacturing practice across the devices we build, and raise and follow up on any gaps found.
- Work day-to-day with the production and manufacturing teams on site.
- Contribute as a regulatory affairs engineer to product-related regulatory activities where manufacturing and distribution are involved.
Qualifications
- Hold a 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.
- Strong understanding of regulatory requirements for device manufacturing.
- Working knowledge of ISO 13485, EU Regulation 2017/745 (MDR), and FDA 21 CFR Part 820, with emphasis on production and process control and device release requirements.
- Familiar 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); knowledge of Swedish is a plus.
- Comfortable using AI tools (e.g., Claude) for research, drafting, and efficiency.
- Experience with Visual Studio Code and Azure DevOps is a plus.
Skills
Required:Regulatory affairs and quality managementDesign transferGMP, ISO 13485, MDR, FDA 21 CFR Part 820
Benefits
- Competitive salary and benefits package.
Last updated Oct 23, 2026. Interested? Apply on the company site.
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