Neko Health - Regulatory Affairs Engineering Lead

• · BSc or MSc degree within law, medicine, pharmacy, engineering, or another relevant scientific discipline; or equivalent professional experience. • · At least 3 years of professional experience in regulatory affairs or quality management for medical devices. • · Working knowledge of EU Regulation 2017/745 (MDR), FDA 21 CFR (including QSR), UK MDR, ISO 13485, ISO 14971, IEC 60601-1 series, IEC 62304, and other applicable standards. • · Experience with regulatory submissions and direct communication with authorities and Notified Bodies across international markets. • · Excellent analytical skills, able to interpret complex regulatory requirements and provide risk-based, practical recommendations. • · Strong writing and communication skills; able to give clear direction to development teams and engage credibly with external stakeholders. • · Highly self-motivated; able to manage multiple workstreams independently and with minimal supervision. • · Fluent in English (oral and written). • Preferred: • · Experience with cardiovascular, cardiac monitoring, or electrophysiology medical devices. • · Proficiency in Swedish. • · Comfortable using AI tools in day-to-day work, particularly tools such as Claude and Microsoft Copilot, to support research, drafting, and operational efficiency. • · Experience with tools such as Visual Studio Code and Azure DevOps. • We use a simplified internal title framework that prioritises clarity over hierarchy, so internal titles may differ from market‑facing role titles. Scope, impact and level of the role are fully aligned and will be clearly discussed throughout the process. • Candidates progress from application and structured screening through thoughtfully designed interviews culminating in a formal offer and final pre-employment checks before joining the team. • Equal Opportunity & Inclusion Statement • Neko Health is committed to inclusive hiring and member-first care. We welcome candidates from all backgrounds and encourage you to request reasonable adjustments to support your application.