Neko Health
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.
Senior Regulatory Affairs Engineer – TCI
Job not on LinkedIn
October 23
Neko Health
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.
📋 Description
• Drive Regulatory Excellence: Ensure our cutting-edge medical devices meet global standards and regulations as well as align with regulatory strategies from research and development to market launch and post-market. • Support Product Development: Advise on regulatory strategy throughout the product lifecycle, influencing design, risk management, supplier selection, and device labeling. • Maintain Regulatory Documentation: Develop and maintain regulatory documentation, including Design History File (DHF), Technical Documentation, as well as Device Master Record (DMR) and Device History Records (DHR). • Own Regulatory Submissions: Prepare, review, and submit documentation for EU MDR, FDA, and other international markets. • Monitor Product Safety: Participate in post-market surveillance, CAPA, and complaint management activities. • Interact with Regulatory Bodies: Coordinate communications with regulatory bodies and drive certification projects and vigilance activities, ensuring timely reporting and compliance. • 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 regulatory affairs or quality management for active medical devices and software as a medical device. • Expertise: Deep knowledge of EU MDR, FDA CFR (Title 21 Subchapter H), UK MDR, ISO 13485, IEC 60601-1, IEC 62304, ISO 14971, and more. • 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.
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