Regional Regulatory Affairs Lead, EMEA

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 across EMEA, we're looking for a regulatory leader to build our regulatory function for the region, based in the UK. ABOUT THE ROLE This is our first regulatory affairs hire in the UK. You'll build the EMEA RA function from the ground up, manage our relationship with the MHRA, and hold the role of UK Responsible Person. Working with the Director of Regulatory Affairs, you'll help shape Neko's global regulatory strategy and bring the EMEA perspective to the table. WHERE YOU'LL MAKE AN IMPACT - Set up the EMEA RA function — core processes, SOPs, and a live in-region quality management system — in close partnership with the Quality team. - Take on and hold the UKRP role and build Neko's relationship with the MHRA. - Build a scalable, country-by-country expansion process, and be the voice of the EMEA markets in Neko's regulatory planning. - Align our position across UK, EU, and other regulatory jurisdictions, and manage post-market regulatory activity for the regions. - Help shape both the EMEA and global RA strategy and define what the future EMEA team looks like. WHAT YOU'LL BRING - 8+ years in medical device regulatory affairs, with at least 5 focused on UK, EU or EMEA-regulated devices. - A solid grasp of the operations behind that expansion — from in-region setup to scaling day-to-day delivery. - A track record as the accountable lead on CE marking under EU MDR, or equivalent clearances in the EMEA regions. - Direct authority engagement — you've planned and led pre-submission and submission meetings with the MHRA or other authorities in the EMEA regions. - Eligibility and willingness to hold the Statutory UK Responsible Person. - Experience building processes, SOPs, or teams in a scale-up or greenfield setting — not just operating within an established function. - 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: 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 UK & EMEA 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 in Sweden to lean on.