Senior Regulatory Affairs Engineer (TCI)
Description
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 working with active medical devices and software as a medical device throughout the product lifecycle.
What You’ll Do
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 withRegulatory 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.
What You Bring
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.