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Neko Health
New York, United States
Source: Neko Health careers · View original posting
From Neko Health's posting. “We” and “our” refer to the employer.
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.
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.
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