Senior Regulatory Affairs Engineer (RA Operations)

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 : 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 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.

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.

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