Senior Regulatory Affairs Engineer

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October 14

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Neko Health

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Healthcare Insurance • Wellness

Neko Health is a healthcare company offering advanced body scans and health check services in the United Kingdom and Sweden. They focus on providing comprehensive health evaluations using cutting-edge technology, allowing clients to receive instant results and detailed consultations with doctors. Their services include monitoring body measurements, blood vessels, heart rhythm, diabetes factors, and skin mapping. Neko Health emphasizes preventive healthcare and annual check-ups to help clients track changes and improve their health over time. The company aims to revolutionize healthcare by making thorough health checks accessible and emphasizing prevention over treatment.

11 - 50 employees

Founded 2018

⚕️ Healthcare Insurance

🧘 Wellness

💰 Series A on 2023-07

📋 Description

• 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.

🎯 Requirements

• Education: BSc or MSc in law, medicine, pharmacy, engineering, or a related field. • Experience: 4–5+ 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.