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neko-health - Regional Regulatory Affairs Lead, EMEA

London+ Equity2d ago

In Office Staff EMEA Medical Devices Digital Health Regulatory Affairs Manager Regulatory Affairs Documentation

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Requirements

• 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. • 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.

Benefits

• 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.