Regional Regulatory Affairs Lead, US

Neko Health•New York, NY

2d•$191,250 - $233,750

About The Position

As Neko grows in the US, we are looking for a regulatory leader to build our regulatory function from the ground up. This is our first regulatory affairs hire in North America. You will set the strategy, shape the day-to-day, and clear the path for our devices in the world's biggest medical device market. You will 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 will help shape Neko's global regulatory strategy and bring the US perspective to the table.

Requirements

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 Haves

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.

Responsibilities

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.