Regional Regulatory Affairs Lead, US

Job description

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. As we grow in the US, we're looking for a regulatory leader to build our regulatory function from the ground up. You'll set the strategy, shape the day-to-day, and clear the path for our devices in the world's biggest medical device market. ABOUT THE ROLE This is our first regulatory affairs hire in North America. You'll build the US RA function from the ground up, manage our relationship with the FDA (including device submissions), and hold the statutory roles of US Agent, Initial Importer, and Medical Device Distributor. Working with the Director of Regulatory Affairs, you'll help shape Neko's global regulatory strategy and bring the US perspective to the table. WHERE YOU'LL MAKE AN IMPACT - Set up the US RA function: core processes, SOPs, and a live, in-region quality management system, working closely with the Quality team. - Manage our relationship with FDA, including device submissions, and guide the implementation of the regulatory pathway for the US device portfolio. - Build a scalable, state-by-state expansion process and be the voice of the US market in Neko's regulatory planning. - Hold the US Agent, Initial Importer, and Medical Device Distributor roles, and manage post-market regulatory activity for the region. - Help shape both the US and global RA strategy and define what the future US team looks like. WHAT YOU'LL BRING - 8+ years in medical device regulatory affairs, with at least 5 focused on FDA-regulated devices. - A track record as the accountable lead on US clearances or approvals: 510(k), De Novo, or PMA. - Direct FDA engagement: you've planned and led pre-submission and submission meetings. - Eligibility and willingness to hold the US Agent, Initial Importer, and Medical Device Distributor roles. - Experience building processes, SOPs, or teams in a scale-up or greenfield setting, not just working within an established one. - Experience supporting clinical expansion into new markets or sites. - A solid grasp of the operations behind that expansion — from in-region setup to scaling day-to-day delivery. - Hands-on experience using AI for regulatory and market intelligence, documentation preparation, and workflow automation - with the judgement to distinguish what to automate from what requires expert oversight. - A degree in a relevant field. NICE TO HAVE - Software as a Medical Device (SaMD) experience alongside a hardware device background. - Experience partnering with product development in medtech or healthtech engineering. - Experience building or scaling a regional regulatory team. WHY NEKO At Neko, you'll get a rare chance to build a regulatory function from the ground up, at a company that believes preventive healthcare can change lives. The package is competitive — base salary, equity, and full benefits — but the real draw is the work itself: a world-class team, and watching what you build reach members across two continents. - Build something lasting: create the US RA function from scratch — the processes, the team, and how the work gets done locally. - A voice in global RA: a genuine say in regulatory decisions from day one, portfolio strategy included. - Real ownership of the US market: backed by a global RA framework that gives you strong support, not a blank check. - Strategy and hands-on depth: big-picture direction and day-to-day technical work in the same role. - An experienced team beside you: a seasoned RA and Quality team to lean on.