Manufacturing Lifecycle Regulatory Engineer

Neko Health AB; Stockholms kommun; Hybrid; SEK 700,000 - 950,000; Full time

Benefits offered by this job

On-site collaboration

Growth opportunities

Competitive benefits

Job summary

Neko Health AB is seeking a Regulatory Affairs Engineer/RA Engineering Lead to drive design transfer and regulatory compliance for manufactured devices. You will work hands-on with production, ensure GMP controls, and manage documentation for global shipments.

Ideal candidates have 3–5 years in medical device regulatory affairs, ISO 13485 and MDR expertise, and strong collaboration with production teams. Swedish knowledge is a plus, and on-site presence is preferred in Stockholm.

Qualifications

• 3–5 years of quality or regulatory affairs experience for medical devices.
• Experience with design transfer or production process validation.
• Fluent in English; Swedish a plus.

Responsibilities

• Support design transfer from engineering into production.
• Maintain regulatory requirements for components and calibration of equipment.
• Prepare documentation for shipments to markets (FDA); coordinate with production.

Skills

Regulatory affairs

Team collaboration

English fluency

Regulatory documentation

Education

BSc or MSc in engineering/tech

Tools

ISO 13485

MDR (EU 2017/745)

FDA 21 CFR Part 820

Job description

Neko Health AB is seeking a Regulatory Affairs Engineer/RA Engineering Lead to drive design transfer and regulatory compliance for manufactured devices. You will work hands-on with production, ensure GMP controls, and manage documentation for global shipments.

Ideal candidates have 3–5 years in medical device regulatory affairs, ISO 13485 and MDR expertise, and strong collaboration with production teams. Swedish knowledge is a plus, and on-site presence is preferred in Stockholm.