Regulatory Affairs Engineering Lead - Heart Program

Mission

Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear. In a single, non-invasive visit under an hour, proprietary technology and direct clinical care combine to deliver personalised, actionable insights. It's a team that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is the norm, and where your work genuinely helps people live longer, healthier lives. Role Purpose

We are seeking a regulatory affairs professional to work with our medical devices in our portfolio of cardiology devices and applications. Depending on experience, the position may be hired as either an RA Engineer or RA Engineering Lead, both reporting to the RA Manager. You will work closely with engineering, clinical, product and project management teams to support regulatory activities across the product lifecycle. The role covers both hardware devices and software as a medical device (SaMD), with strong focus on EU MDR technical documentation, FDA submissions, post-market activities and regulatory guidance during development. This role is suited for someone who is hands-on, comfortable working cross-functionally, and able to apply regulatory requirements pragmatically in a fast-moving development environment. What You’ll Be Responsible For

· Provide regulatory guidance throughout the product lifecycle, from development to market launch. · Support development and maintenance of regulatory strategies for cardiological devices and software, covering classification positions, intended use, and market entry sequencing. · Prepare and maintain EU MDR Technical Documentation and other regulatory dossiers. · Support FDA premarket submissions and product registrations in applicable markets. · Assess the regulatory impact of design and process changes and support change control activities. · Contribute to device labelling and traceability activities. · Participate in risk management activities in line with ISO 14971. · Support post-market surveillance, PMCF, vigilance, CAPA, and complaint handling activities. · Contribute to internal and external audits, including Notified Body audits. · Collaborate with engineering, clinical, product, and quality teams on regulatory and compliance matters.