Regulatory Affairs Engineering Lead, Clinical Evaluation

Own the clinical side of Neko's regulatory work. You'll write clinical evaluation plans and reports, and clinical documentation behind submissions to the FDA, EU and UK. Neko generates its own clinical evidence, so this is authored work. You'd plan and support clinical studies under ISO 14155, appraise clinical data behind each claim, and keep the clinical evaluation current as devices change.

What you'll do

• Write clinical evaluation plans and clinical evaluation reports under EU MDR Annexes XIV and XV, including the literature review and the appraisal of clinical data behind them
• Own the regulatory side of clinical studies and clinical investigations, from study design input through to clinical investigation submissions, under ISO 14155, UK MDR 2002 and FDA 21 CFR
• Build the regulatory strategy for clinical evidence across EU MDR, FDA and UK MDR, and turn it into a prioritised roadmap the engineering and product teams can work to
• Prepare submissions and maintain the clinical sections of technical files, pulling together engineering, clinical and quality input for notified body or agency review
• Give regulatory guidance to the hardware and software teams on IEC 62304, IEC 60601-1 and IEC 62366-1, so those requirements are part of how the devices get built
• Assess the regulatory and clinical impact of device changes, hardware and software, and support change control
• Own post-market surveillance and post-market clinical follow-up from the clinical evidence side, including regulatory change monitoring and incident reporting
• Design and deliver regulatory and clinical evaluation training for process owners and product teams

What you'll need

• You have personally authored clinical evaluation plans and reports, clinical investigation plans, or clinical study protocols for medical devices
• Medical device regulatory experience under EU MDR, and under at least one of FDA 21 CFR or UK MDR 2002
• Clinical evaluation methodology: MEDDEV 2.7/1 Rev 4 and current MDCG guidance
• Clinical investigation requirements under ISO 14155, applied to real studies
• Hands-on submission preparation, with the clinical documentation as your part of it
• Comfortable across hardware and software regulatory requirements, including IEC 62304, IEC 60601-1 and IEC 62366-1
• A risk-based, proportionate approach to compliance, and the judgement to tell what needs regulating from what doesn't
• BSc or MSc in engineering, or in another relevant scientific discipline

Nice to have

• A research or clinical science background
• Post-market clinical follow-up and PMCF plans
• Wearables, imaging or screening devices, where the company generated its own clinical evidence
• ISO 14971 risk management and IEC 62366-1 usability applied in product development
• ISO 13485 quality management systems, and embedding regulatory requirements into QMS processes