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.
11 - 50 employees
Founded 2018
⚕️ Healthcare Insurance
🧘 Wellness
💰 Series A on 2023-07
Senior Regulatory Affairs Engineer – RA Operations
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.
11 - 50 employees
Founded 2018
⚕️ Healthcare Insurance
🧘 Wellness
💰 Series A on 2023-07
📋 Description
• Assign Product Codes and IDs: Define, review, assign, and keep up-to-date necessary codes (EMDN, GMDN, UDI, etc) for our medical devices. • Own Product Registrations: Prepare, review and submit product registrations for applicable markets. • Maintain Establishment Listings and Reporting: Obtain and maintain any establishment/operating licenses necessary for the activity as a medical device manufacturer, distributor or importer. Also, ensure reporting of requested information is performed in a timely manner (e.g. for ISO 14001, REACH, RoHS). • Manage Legal Representatives: Ensure legal representatives are designated, necessary contracts are established, necessary internal processes are established. • Drive Regulatory Intelligence: Monitor the regulatory landscape to catch new regulations, standards, trends and ensure that impact is analyzed and implemented to keep Neko Health at the forefront of compliance. • Support Product Development: Advise on regulatory strategy throughout the product lifecycle with specific focus on device labeling for multiple markets. • 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.
🎯 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, 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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