Regional Regulatory Affairs Lead, EMEA

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, before symptoms appear.

Responsibilities

• Set up the EMEA RA function, including core processes, SOPs, and a live in-region quality management system
• Take on and hold the UKRP role and build Neko's relationship with the MHRA
• Build a scalable, country-by-country expansion process for EMEA markets
• Align regulatory positions across UK, EU, and other jurisdictions
• Manage post-market regulatory activity for the regions
• Help shape both the EMEA and global RA strategy

Requirements

• 8+ years in medical device regulatory affairs
• 5+ years focused on UK, EU, or EMEA-regulated devices
• Track record as accountable lead on CE marking under EU MDR or equivalent clearances
• Experience leading pre-submission and submission meetings with the MHRA or other EMEA authorities
• Eligibility and willingness to hold the Statutory UK Responsible Person role
• Experience building processes, SOPs, or teams in a scale-up or greenfield setting
• 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