Senior Regulatory Affairs Engineer (RA Operations)

This a Full Remote job, the offer is available from: Europe 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. This offer from "Neko Health" has been enriched by Jobgether.com and got a 0% flex score. Apply tot his job