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

• Establish full ownership of EU MDR Technical Documentation and regulatory dossiers for dermatological hardware and SaMD products
• Support or lead FDA premarket submissions or CE marking activities
• Act as the primary regulatory contact for engineering, clinical, and product teams
• Participate in design reviews and change control processes
• Contribute to post-market surveillance, PMCF, vigilance, and complaint handling activities

Requirements

• BSc or MSc 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 Notified Bodies
• Strong analytical and technical writing skills
• Fluent in English

Preferred Qualifications

• Experience with active devices and Software as a Medical Device (SaMD)
• Experience with dermatology-adjacent medical devices
• Proficiency in Swedish
• Experience using AI tools like Claude or Microsoft Copilot
• Experience with Visual Studio Code and Azure DevOps