Senior Regulatory Affairs Engineer

Senior Regulatory Affairs Engineer

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.

We are looking for you that have extensive experience from software development, artificial intelligence, and machine learning in the medical device space.

What You'll Do

Drive Regulatory Excellence : Ensure our cutting-edge software meets global standards and regulations as well as align with regulatory strategies from research and development to market launch and post-market.

Implement Regulatory Requirements for AI and ML : Coordinate activities and efforts across AI and ML algorithms and device software implementation and ensure regulatory requirements are implemented in our processes.

Support Software Development : Advise on regulatory strategy throughout the software lifecycle, influencing architecture and design, risk management, supplier selection, and labeling.

Prepare Software Documentation : Participate in activities to prepare necessary software documentation for our software modules, components, algorithms, and devices as needed.

Empower Process Owners and Teams : Guide process owners and product teams to integrate regulatory requirements into our Quality Management System and deliver impactful training on compliance and regulatory topics.

Stay Ahead : Monitor regulatory trends and provide intelligence to keep Neko Health at the forefront of compliance.

What You Bring

Education : BSc or MSc in law, medicine, pharmacy, engineering, or a related field.

Experience : 45+ years in software development with artificial intelligence and machine learning algorithms. Experience from regulatory affairs or quality management for software as a medical device is a plus.

Expertise : Deep knowledge of EU AI Act, FDA AI Guidance, IEC 62304, IEC 82304-1, IEC 81001-5-1. Knowledge of EU MDR, FDA CFR (Title 21 Subchapter H), UK MDR, ISO 13485, ISO 14971, and more is a plus.

Skills : Analytical, detail-oriented, and able to interpret complex regulations to provide risk-based recommendations.

Communication : Excellent interpersonal and writing skills; able to engage and inspire both internal teams and external stakeholders.

Mindset : Self-motivated, independent, and ready to take ownership in a dynamic, quality-focused environment.

Languages : Fluent English required; Swedish proficiency is a plus.