Regional Regulatory Affairs Lead, US

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.

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.