Compared with the selected benchmark ("All roles in New York, United States"), this listing's salary midpoint is about 69% higher. The offer still falls within the benchmark range (€2,208–€18,809). The listed pay band (€15,938–€19,479) is tighter than the benchmark, which suggests lower salary variability. This benchmark is based on 6 comparable listings.

Monthly salary comparison for Regional Regulatory Affairs Lead
Market	Lower bound (25th percentile)	Median	Upper bound (75th percentile)
All roles in New York, United States	€2,208/per month	€10,779/per month	€18,809/per month

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.

Job Details

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 Nekos 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

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