Neko Health · 2 months ago
Senior Regulatory Affairs Engineer (AI/ML)
United States
Full-time
Remote
Mid, Senior Level
4+ years expNeko Health is seeking a Senior Regulatory Affairs Engineer who’s passionate about tackling complex regulatory strategies in the medical technology field. The role involves ensuring compliance with global standards for software, particularly in the areas of artificial intelligence and machine learning, while guiding teams and monitoring regulatory trends.
Artificial Intelligence (AI)Health CareHospital
Responsibilities
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
Qualification
Required
BSc or MSc in law, medicine, pharmacy, engineering, or a related field
4–5+ years in software development with artificial intelligence and machine learning algorithms
Deep knowledge of EU AI Act, FDA AI Guidance, IEC 62304, IEC 82304-1, IEC 81001-5-1
Analytical, detail-oriented, and able to interpret complex regulations to provide risk-based recommendations
Excellent interpersonal and writing skills; able to engage and inspire both internal teams and external stakeholders
Self-motivated, independent, and ready to take ownership in a dynamic, quality-focused environment
Fluent English required
Preferred
Experience from regulatory affairs or quality management for software as a medical device
Knowledge of EU MDR, FDA CFR (Title 21 Subchapter H), UK MDR, ISO 13485, ISO 14971, and more
Swedish proficiency
Company
Neko Health
Neko Health develops scanning technology for preventive healthcare and early detection.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
$325.13MKey Investors
Lightspeed Venture PartnersLakestar
2025-01-22Series B· $260M
2023-07-05Series A· $65.13M
Leadership Team
Hjalmar Nilsonne
Founder & CEO
Recent News
2026-01-07
Tech Funding News
2025-11-08
2025-10-27
Company data provided by crunchbase