Regulatory Affairs Engineer — Clinical Evidence Lead

Neko Health AB; Greater London; On-site; GBP 70,000 - 100,000; Full time

Job summary

Neko Health AB seeks a regulatory affairs engineer to own the clinical regulatory work for our devices, drafting clinical evaluation plans and reports and supporting submissions to the FDA, EU and UK.

The role spans hardware and software, collaborating with engineering, clinical and quality teams, and emphasizes ISO 14155, IEC standards, and post-market surveillance throughout product development.

Qualifications

• Authored clinical evaluation plans and reports or clinical study protocols for medical devices
• Regulatory experience under EU MDR and FDA/UK MDR
• Clinical evaluation methodology: MEDDEV 2.7/1 Rev 4 and MDCG guidance
• Clinical investigation requirements under ISO 14155
• Hands-on submission preparation with clinical documentation

Responsibilities

• Write clinical evaluation plans and clinical evaluation reports under EU MDR Annexes XIV and XV, including literature review and data appraisal
• Own regulatory side of clinical studies and investigations from design input to submissions under ISO 14155, UK MDR 2002 and FDA 21 CFR
• Build regulatory strategy for clinical evidence across EU MDR, FDA and UK MDR and translate into a prioritised roadmap for engineering/product teams
• Prepare submissions and maintain clinical sections of technical files for review by notified bodies or agencies
• Provide regulatory guidance on IEC 62304, IEC 60601-1 and IEC 62366-1 to hardware/software teams
• Assess regulatory/clinical impact of device changes and support change control
• Own post-market surveillance and PMCF plans and regulatory change monitoring
• Design and deliver regulatory/clinical evaluation training for process owners and product teams
• Support internal and external audits, including notified body/agency interactions

Skills

Regulatory affairs (EU MDR)

Clinical evaluation planning

ISO 14155

Medical device submissions

Regulatory strategy

Education

BSc or MSc in engineering or relevant science

Job description

Neko Health AB seeks a regulatory affairs engineer to own the clinical regulatory work for our devices, drafting clinical evaluation plans and reports and supporting submissions to the FDA, EU and UK.

The role spans hardware and software, collaborating with engineering, clinical and quality teams, and emphasizes ISO 14155, IEC standards, and post-market surveillance throughout product development.