Neko Health
Regional Regulatory Affairs Lead, US
Part remote, part office, you need to live within commuting distance of a named location.
Hybrid · New York
Employer listed it 3 months ago · Added yesterday
Been open since 3 months ago. Long-running listings are sometimes left up after the role is filled.
Salary
$191,250 to $233,750
Location
Hybrid · New York
Timezone
Not stated
Contract
Full-time
Experience
Lead
Category
Other
Published by the employer
Remote flexibility
Hybrid
This role is only partly remote, the employer expects time in the office around New York, Hybrid, so you need to live within commuting distance.
What the employer says
- Source listing states candidate location: "New York, Hybrid"
- Listing mentions "Hybrid"
What Nomaders makes of it
- Not suitable if you plan to move between countries
The quotes above are the employer's own words; the reading is ours. Always check the original listing and employment terms before working from another country.
About the role
Mission
Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear. In a single, non-invasive visit under an hour, proprietary technology and direct clinical care combine to deliver personalised, actionable insights. It's a team that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is the norm, and where your work genuinely helps people live longer, healthier lives.
As we grow in the US, we're looking for a regulatory leader to build our regulatory function from the ground up. You'll set the strategy, shape the day-to-day, and clear the path for our devices in the world's biggest medical device market.
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.
Where you'll make an 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.
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.
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.
Benefits
No benefits package published with this listing. Ask about it at first interview.
How to apply
- 1Check the flexibility label above, hybrid, matches where you plan to live and work.
- 2Tailor your CV to the role at Neko Health, mentioning your remote working experience.
- 3Apply directly on the employer's careers page using the button below. Nomaders never handles your application.
Found 1d ago. Last checked 23 Sept. Always confirm the details on the original posting, salary and location can change after publication.
Listing sourced from Company boards.
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