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.
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