Regional Regulatory Affairs Lead, US

About Neko Health

Neko is redefining preventative healthcare through data-driven insights.

What you'd do

• Set up the US RA function and quality management system
• Manage device submissions to the FDA
• Build a scalable state-by-state expansion process
• Hold roles like US Agent and Medical Device Distributor

What they're looking for

• 8+ years in medical device regulatory affairs
• Track record of US clearances or approvals
• Direct FDA engagement experience
• Willingness to hold key regulatory roles

Perks

• Create a regulatory function from scratch
• Voice in global regulatory decisions
• Real ownership of the US market