What You’ll DoAssign 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.What You BringEducation: 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.Are you ready to shape the future of medical technology? Neko Health is seeking a Senior Regulatory Affairs Engineer who’s passionate about tackling complex regulatory strategies, enjoys working with cutting‑edge medical devices, and thrives in a fast‑paced, collaborative and distributed environment.We are looking for someone who has extensive experience from keeping the regulatory affairs wheels spinning, keeping registrations of multiple devices in multiple markets current. #J-18808-Ljbffr