Regulatory Affairs Lead, Clinical Evaluation

Neko Health; Stockholms kommun; On-site; SEK 700,000 - 950,000; Full time

Job summary

Neko Health is seeking a regulatory affairs engineer to own the clinical side of regulatory work for medical devices. You will write clinical evaluation plans and reports, and manage clinical documentation for submissions to the FDA, EU, and UK.

You’ll plan and support clinical studies under ISO 14155, appraise the literature behind each claim, and keep the clinical evaluation current as devices evolve. This hands-on role spans hardware and software, collaborating with engineering, clinical, and

Qualifications

• Authored clinical evaluation plans and reports, or study protocols for medical devices
• Regulatory experience under EU MDR and FDA/UK MDR
• Clinical evaluation methodology and ISO 14155 knowledge
• Hands-on submission preparation with clinical documentation
• Risk-based approach to device regulation and compliance
• Fluent English; engineering background (BSc/MSc)

Responsibilities

• Write clinical evaluation plans and clinical evaluation reports under EU MDR Annexes XIV and XV
• Own regulatory side of clinical studies and investigations under ISO 14155, UK MDR 2002 and FDA 21 CFR
• Build regulatory strategy for clinical evidence across EU MDR, FDA and UK MDR
• Prepare submissions and maintain clinical sections of technical files
• Provide regulatory guidance on IEC 62304, IEC 60601-1 and IEC 62366-1 to engineering teams
• Assess regulatory/clinical impact of device changes and support change control
• Own post-market surveillance and PMCF plans from regulatory perspective
• Design and deliver regulatory and clinical evaluation training for process owners
• Support audits and agency interactions

Skills

Clinical evaluation

Regulatory affairs

EU MDR

FDA / UK MDR

ISO 14155

Regulatory submissions

IEC 62304

IEC 60601-1

IEC 62366-1

Fluent English

Education

BSc/MSc in engineering

Job description

Neko Health is seeking a regulatory affairs engineer to own the clinical side of regulatory work for medical devices. You will write clinical evaluation plans and reports, and manage clinical documentation for submissions to the FDA, EU, and UK.

You’ll plan and support clinical studies under ISO 14155, appraise the literature behind each claim, and keep the clinical evaluation current as devices evolve. This hands-on role spans hardware and software, collaborating with engineering, clinical, and