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 fromkeeping the regulatory affairs wheels spinning, keeping registrations of multiple devices in multiple markets current.
What You’ll Do 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: Monitorthe regulatory landscape tocatch 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 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, 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.
