Senior Regulatory Affairs Engineer

This a Full Remote job, the offer is available from: Europe 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 Engineerwho’s passionate about tackling complex regulatory strategies, enjoys working with cutting-edge medical devices, and thrives in a fast-paced, collaborativeand 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: 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. This offer from "Neko Health" has been enriched by Jobgether.com and got a 0% flex score. Apply tot his job