Regional Regulatory Affairs Lead

Neko Health

Regulatory Affairs Lead establishing US regulatory function for medical devices at Neko. Managing FDA relationships and guiding regulatory strategies for market expansion.

Posted 6/18/2026full-timeNew York City • New York • 🇺🇸 United StatesSenior💰 $191,250 - $233,750 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Competitive package including base salary and equity
Full benefits

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory affairsFDA submissions510(k)De NovoPMASOPsprocess buildingclinical expansionworkflow automationAI for regulatory intelligence

Soft Skills

leadershipcommunicationrelationship managementstrategic planningteam buildingjudgmentproblem-solvingorganizational skillsadaptabilitycollaboration