Neko Health · 2 months ago
Senior Regulatory Affairs Engineer (RA Operations)
United States
Full-time
Remote
Mid, Senior Level
4+ years expNeko Health is seeking a Senior Regulatory Affairs Engineer who’s passionate about tackling complex regulatory strategies and enjoys working with cutting-edge medical devices. The role involves managing product registrations, maintaining regulatory compliance, and advising on regulatory strategy throughout the product lifecycle.
Artificial Intelligence (AI)Health CareHospital
Responsibilities
Define, review, assign, and keep up-to-date necessary codes (EMDN, GMDN, UDI, etc) for our medical devices
Prepare, review and submit product registrations for applicable markets
Obtain and maintain any establishment/operating licenses necessary for the activity as a medical device manufacturer, distributor or importer
Ensure legal representatives are designated, necessary contracts are established, necessary internal processes are established
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
Advise on regulatory strategy throughout the product lifecycle with specific focus on device labeling for multiple markets
Guide process owners and product teams to integrate regulatory requirements into our Quality Management System and deliver impactful training on compliance and regulatory topics
Qualification
Required
BSc or MSc in law, medicine, pharmacy, engineering, or a related field
4–5+ years in regulatory affairs or quality management for active medical devices and software as a medical device
Deep knowledge of EU MDR, FDA CFR (Title 21 Subchapter H), UK MDR, ISO 13485, and more
Analytical, detail-oriented, and able to interpret complex regulations to provide risk-based recommendations
Excellent interpersonal and writing skills; able to engage and inspire both internal teams and external stakeholders
Self-motivated, independent, and ready to take ownership in a dynamic, quality-focused environment
Fluent English required
Preferred
Swedish proficiency is a plus
Company
Neko Health
Neko Health develops scanning technology for preventive healthcare and early detection.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
$325.13MKey Investors
Lightspeed Venture PartnersLakestar
2025-01-22Series B· $260M
2023-07-05Series A· $65.13M
Leadership Team
Hjalmar Nilsonne
Founder & CEO
Recent News
General Catalyst
2026-01-20
2026-01-16
2026-01-07
Company data provided by crunchbase