Regulatory Affairs Engineer (Medical Devices)

Location: Stockholm, Sweden; hybrid with regular on-site presence required near the manufacturing site.

Company

hirify.global develops and manufactures non-invasive medical devices and combines proprietary technology with direct clinical care to support preventative healthcare.

What you will do

• Support the transfer of products from engineering into production as a controlled design-transfer process.
• Maintain regulatory controls for incoming components, manufacturing equipment calibration, and equipment maintenance.
• Manage manufacturing and device-release records created during production.
• Prepare shipment, customs, and FDA documentation for devices exported to other markets, particularly the US.
• Coordinate shipments with production and ensure declarations to the FDA are properly supported.
• Monitor good manufacturing practice, follow up on gaps, and contribute to product-related regulatory activities involving manufacturing and distribution.

Requirements

• Three to five years of quality or regulatory affairs experience in medical devices, with direct manufacturing exposure.
• Knowledge of ISO 13485, EU Regulation 2017/745 (MDR), and FDA 21 CFR Part 820, especially production, process control, and device release requirements.
• Experience with design transfer or production process validation and with export, FDA import, and customs documentation.
• BSc or MSc in engineering, a relevant scientific or technical discipline, or equivalent professional experience.
• Fluent English, both written and spoken; regular on-site work with the production team in Stockholm is required.
• Comfort using AI tools such as Claude for research, drafting, and operational efficiency.

Nice to have

• Knowledge of Swedish.
• Experience with Visual Studio Code and Azure DevOps.

Culture & Benefits

• Hybrid work with direct collaboration on site with production, engineering, and quality teams.
• End-to-end ownership in a company that designs and manufactures its own hardware.
• Guidance from an experienced RA Engineering Lead and the opportunity to grow into broader ownership.
• Small, experienced regulatory team with visible impact on manufacturing and distribution.
• Competitive salary and benefits package.