Senior Regulatory Affairs Engineer - Remote

Overview

Join Neko Health as Senior Regulatory Affairs Engineer. Are you ready to shape the future of medical technology? Neko Health is seeking a Senior Regulatory Affairs Engineer who’s passionate about tackling complex regulatory strategies, enjoys working with cutting-edge medical devices, and thrives in a fast-paced, collaborative and distributed environment.

In Short

• Drive Regulatory Excellence: Ensure our cutting-edge software meets global standards and regulations.
• Implement Regulatory Requirements for AI and ML: Coordinate activities across AI and ML algorithms.
• Support Software Development: Advise on regulatory strategy throughout the software lifecycle.
• Prepare Software Documentation: Participate in preparing necessary software documentation.
• Empower Process Owners and Teams: Guide teams to integrate regulatory requirements into the Quality Management System.
• Stay Ahead: Monitor regulatory trends to keep Neko Health compliant.

Requirements

• Education: BSc or MSc in law, medicine, pharmacy, engineering, or a related field.
• Experience: 4–5+ years in software development with AI and ML algorithms.
• Expertise: Knowledge of EU AI Act, FDA AI Guidance, IEC 62304, IEC 82304-1.
• Skills: Analytical, detail-oriented, able to interpret complex regulations.
• Communication: Excellent interpersonal and writing skills.
• Mindset: Self-motivated and ready to take ownership in a dynamic environment.
• Languages: Fluent English required; Swedish proficiency is a plus.

Benefits

• Opportunity to work with cutting-edge medical technology.
• Collaborative and distributed work environment.
• Impactful role in shaping regulatory strategies.