Neko Health
Regional Regulatory Affairs Lead, US
$191K–$234K
New York · Hybrid · Full-time · Posted Jun 18, 2026
- Experience
- 8+ years in medical device regulatory affairs, with at least 5 focused on FDA-regulated devices.
- Education
- A degree in a relevant field.
About the job
Build and lead Neko Health’s US regulatory affairs function, manage FDA engagement and device submissions, and support regional expansion and global regulatory strategy.
What you'll do
- Establish US regulatory processes, SOPs, and an in-region quality management system.
- Manage FDA engagement, device submissions, US regulatory pathways, and post-market activity.
- Hold the US Agent, Initial Importer, and Medical Device Distributor roles and support state-by-state expansion.
What they ask for
- 8+ years in medical device regulatory affairs, including at least 5 focused on FDA-regulated devices.
- Accountable lead experience on US clearances or approvals: 510(k), De Novo, or PMA; and direct experience planning and leading FDA pre-submission and submission meetings.
- Eligible and willing 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; clinical expansion support; hands-on AI use for regulatory work; and a relevant degree.
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, or building/scaling a regional regulatory team.
Pay
$191,250 – $233,750 (base salary)
Tools
510(k), De Novo, PMA, Software as a Medical Device (SaMD)
AI focus
Use AI for regulatory and market intelligence, documentation preparation, and workflow automation, applying expert judgment about what to automate versus what needs oversight.
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