Regulatory Affairs Engineering Lead

About the Company

Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission is to make data-driven, preventative care accessible to more people, before symptoms appear.

Responsibilities

• Provide regulatory guidance throughout the product lifecycle, from development to market launch
• Support development and maintenance of regulatory strategies for cardiological devices and software
• Prepare and maintain EU MDR Technical Documentation and other regulatory dossiers
• Support FDA premarket submissions and product registrations in applicable markets
• Assess the regulatory impact of design and process changes and support change control activities
• Contribute to device labelling and traceability activities
• Participate in risk management activities in line with ISO 14971
• Support post-market surveillance, PMCF, vigilance, CAPA, and complaint handling activities
• Contribute to internal and external audits, including Notified Body audits
• Collaborate with engineering, clinical, product, and quality teams on regulatory and compliance matters

Requirements

• BSc or MSc degree in law, medicine, pharmacy, engineering, or a relevant scientific discipline
• At least 3 years of professional experience in regulatory affairs or quality management for medical devices
• Working knowledge of EU MDR, FDA 21 CFR, UK MDR, ISO 13485, ISO 14971, IEC 60601-1, and IEC 62304
• Experience with regulatory submissions and communication with authorities and Notified Bodies
• Excellent analytical and writing skills
• Fluent in English

Preferred Qualifications

• Experience with cardiovascular, cardiac monitoring, or electrophysiology medical devices
• Proficiency in Swedish
• Experience using AI tools like Claude or Microsoft Copilot
• Experience with Visual Studio Code and Azure DevOps