Regulatory Affairs Engineering Lead, Clinical Evaluation

The role

This person will own the clinical side of regulatory work by writing clinical evaluation plans and reports. They will plan and support clinical studies and investigations for hardware and software devices.

What you will do

• Write clinical evaluation plans and reports under EU MDR Annexes XIV and XV
• Own the regulatory side of clinical studies and investigations under ISO 14155, UK MDR 2002 and FDA 21 CFR
• Build the regulatory strategy for clinical evidence across EU MDR, FDA and UK MDR
• Prepare submissions and maintain clinical sections of technical files
• Give regulatory guidance to hardware and software teams on IEC 62304, IEC 60601-1 and IEC 62366-1
• Assess the regulatory and clinical impact of device changes
• Own post-market surveillance and post-market clinical follow-up
• Design and deliver regulatory and clinical evaluation training
• Support internal and external audits

Required qualifications

• 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
• Comfortable across hardware and software regulatory requirements, including IEC 62304, IEC 60601-1 and IEC 62366-1
• A risk-based, proportionate approach to compliance
• Fluent English
• 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
• Mentoring colleagues on regulatory or clinical evaluation topics
• Experience inside a fast-growing health technology company
• Fluent Swedish

About the company

Neko is redefining what prevention means by making data-driven, preventative care accessible. They use proprietary technology and direct clinical care to deliver personalised, actionable insights.