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Neko Health is seeking a Regulatory Affairs Engineer to own the clinical side of regulatory work for its preventative healthcare platform. The role involves authoring clinical evaluation plans and reports, clinical documentation for FDA, EU, and UK submissions, and managing the clinical evidence strategy across multiple regulatory jurisdictions.
Key responsibilities include:
- Author clinical evaluation plans and reports under EU MDR Annexes XIV and XV, including literature reviews and clinical data appraisal
- Own regulatory aspects of clinical studies and investigations under ISO 14155, UK MDR 2002, and FDA 21 CFR, from design through submission
- Build and execute clinical evidence strategy across EU MDR, FDA, and UK MDR frameworks; translate into prioritized roadmaps for engineering and product teams
- Prepare submissions and maintain clinical sections of technical files for notified body and agency review
- Provide regulatory guidance to hardware and software teams on IEC 62304, IEC 60601-1, and IEC 62366-1 standards
- Assess regulatory and clinical impact of device changes; support change control processes
- Manage post-market surveillance and post-market clinical follow-up, including regulatory monitoring and incident reporting
- Design and deliver regulatory and clinical evaluation training for process owners and product teams
- Support internal and external audits, including notified body and regulatory agency interactions
Neko generates its own clinical evidence, so this is hands-on, authored work spanning both hardware and software. You would work closely with engineering, clinical, and quality teams in a small regulatory function.
REQUIREMENTS
Must-have:
- Personal authorship of clinical evaluation plans/reports, clinical investigation plans, or clinical study protocols for medical devices
- Medical device regulatory experience under EU MDR and at least one of: FDA 21 CFR or UK MDR 2002
- Clinical evaluation methodology expertise: MEDDEV 2.7/1 Rev 4 and current MDCG guidance
- Hands-on application of ISO 14155 clinical investigation requirements to real studies
- Hands-on submission preparation with clinical documentation responsibility
- Comfort across hardware and software regulatory requirements (IEC 62304, IEC 60601-1, IEC 62366-1); ability to translate standards into actionable engineer guidance
- Risk-based, proportionate compliance approach with judgment on regulatory necessity
- Fluent English
- BSc or MSc in engineering or relevant scientific discipline
Nice-to-have:
- Research or clinical science background
- Post-market clinical follow-up and PMCF plan experience
- Wearables, imaging, or screening device experience with company-generated clinical evidence
- ISO 14971 risk management and IEC 62366-1 usability in product development
- ISO 13485 quality management systems and regulatory embedding in QMS
- Mentoring colleagues on regulatory or clinical evaluation topics
- Fast-growing health technology company experience
- Fluent Swedish
