Senior Regulatory Affairs Engineer (AI/ML)

About the Role

Join Neko Health to shape the future of medical technology by ensuring our cutting-edge AI/ML-driven software meets complex global regulatory standards from development through market launch.

Responsibilities

• Drive regulatory excellence by ensuring software aligns with global standards across the entire lifecycle (R&D to post-market).
• Coordinate and implement specific regulatory requirements for Artificial Intelligence (AI) and Machine Learning (ML) algorithms and device software.
• Advise product and development teams on regulatory strategy, influencing architecture, design, risk management, and labeling decisions.
• Prepare and contribute to necessary regulatory documentation for software modules, components, and algorithms.
• Guide process owners and product teams in integrating regulatory requirements into the Quality Management System (QMS) and deliver compliance training.
• Monitor regulatory trends to maintain Neko Health's forefront position in compliance.

Requirements

• BSc or MSc in law, medicine, pharmacy, engineering, or a related technical field.
• 4–5+ years of experience in software development, specifically involving Artificial Intelligence and Machine Learning algorithms.
• Deep knowledge of key regulatory standards including EU AI Act, FDA AI Guidance, IEC 62304, IEC 82304-1, and IEC 81001-5-1.
• Analytical, detail-oriented mindset capable of interpreting complex regulations to provide risk-based recommendations.
• Excellent written and verbal communication skills, able to engage and inspire internal and external stakeholders.
• Fluency in English is required.

Nice-to-Haves

• Experience in regulatory affairs or quality management specifically for Software as a Medical Device (SaMD).
• Knowledge of EU MDR, FDA CFR (Title 21 Subchapter H), UK MDR, ISO 13485, and ISO 14971.
• Proficiency in Swedish.