Senior Regulatory Affairs Engineer (RA Operations)

About the Role

Are you ready to shape the future of medical technology? Join Neko Health as a Senior Regulatory Affairs Engineer to drive complex regulatory strategies and ensure compliance for cutting-edge medical devices across multiple international markets.

Responsibilities

• Define, review, assign, and maintain necessary product codes (EMDN, GMDN, UDI, etc.) for medical devices.
• Prepare, review, and submit product registrations for applicable markets.
• Obtain and maintain establishment/operating licenses and ensure timely reporting (e.g., ISO 14001, REACH, RoHS).
• Manage legal representatives, including contract establishment and internal process setup.
• Monitor the regulatory landscape, analyze impacts of new regulations, and implement necessary changes.
• Advise product development teams on regulatory strategy throughout the lifecycle, focusing on device labeling for diverse markets.
• Guide process owners in integrating regulatory requirements into the Quality Management System and deliver compliance training.

Requirements

• BSc or MSc in law, medicine, pharmacy, engineering, or a related field.
• 4–5+ years of experience in regulatory affairs or quality management specifically for active medical devices and Software as a Medical Device (SaMD).
• Deep knowledge of EU MDR, FDA CFR (Title 21 Subchapter H), UK MDR, and ISO 13485.
• Proven ability to interpret complex regulations and provide risk-based recommendations.
• Excellent written and verbal communication skills, capable of engaging internal and external stakeholders.
• Self-motivated, independent, and ready to take ownership in a dynamic, quality-focused environment.
• Fluent English proficiency is required; Swedish proficiency is a plus.

Role Impact

This role is critical for maintaining the regulatory compliance and market access of Neko Health's innovative medical technology portfolio, ensuring our products reach users safely and legally across Europe and beyond.