Regional Regulatory Affairs Lead

About the Company

Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission is to make data-driven, preventative care accessible to more people through proprietary technology and direct clinical care.

Responsibilities

• Set up the US RA function including core processes, SOPs, and a live, in-region quality management system
• Manage the relationship with the FDA, including device submissions and regulatory pathway implementation
• Build a scalable, state-by-state expansion process for the US market
• Hold statutory roles including US Agent, Initial Importer, and Medical Device Distributor
• Manage post-market regulatory activity for the US region
• Help shape both US and global regulatory affairs strategy

Requirements

• 8+ years in medical device regulatory affairs
• 5+ years focused on FDA-regulated devices
• Proven track record as accountable lead on US clearances or approvals (510(k), De Novo, or PMA)
• Direct experience leading pre-submission and submission meetings with the FDA
• Eligibility and willingness to hold US Agent, Initial Importer, and Medical Device Distributor roles
• Experience building processes, SOPs, or teams in a scale-up or greenfield setting
• Experience supporting clinical expansion into new markets or sites
• Hands-on experience using AI for regulatory intelligence and workflow automation
• Degree in a relevant field

Preferred Qualifications

• Software as a Medical Device (SaMD) experience
• Hardware device background
• Experience partnering with product development in medtech or healthtech engineering
• Experience building or scaling a regional regulatory team