Regional Regulatory Affairs Lead

Neko Health

Regulatory leader building the EMEA RA function at Neko, redefining preventative healthcare access through data-driven insights.

Posted 6/18/2026full-timeLondon • 🇬🇧 United KingdomSeniorWebsite

About the role

Key responsibilities & impact

Set up the EMEA RA function — core processes, SOPs, and a live in-region quality management system — in close partnership with the Quality team.
Take on and hold the UKRP role and build Neko's relationship with the MHRA.
Build a scalable, country-by-country expansion process, and be the voice of the EMEA markets in Neko's regulatory planning.
Align our position across UK, EU, and other regulatory jurisdictions, and manage post-market regulatory activity for the regions.
Help shape both the EMEA and global RA strategy and define what the future EMEA team looks like.

Requirements

What you’ll need

8+ years in medical device regulatory affairs, with at least 5 focused on UK, EU or EMEA-regulated devices.
A solid grasp of the operations behind that expansion — from in-region setup to scaling day-to-day delivery.
A track record as the accountable lead on CE marking under EU MDR, or equivalent clearances in the EMEA regions.
Direct authority engagement — you've planned and led pre-submission and submission meetings with the MHRA or other authorities in the EMEA regions.
Eligibility and willingness to hold the Statutory UK Responsible Person.
Experience building processes, SOPs, or teams in a scale-up or greenfield setting — not just operating within an established function.
Hands-on experience using AI for regulatory and market intelligence, documentation preparation, and workflow automation - with the judgement to distinguish what to automate from what requires expert oversight.
A degree in a relevant field.

Benefits

Comp & perks

Base salary, equity, and full benefits

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory affairsCE markingEU MDRprocess buildingSOP developmentmarket intelligencedocumentation preparationworkflow automationmedical device regulationspost-market regulatory activity

Soft Skills

leadershiprelationship buildingstrategic planningcommunicationaccountabilitycollaborationproblem-solvingjudgmentadaptabilityteam building

Certifications

Statutory UK Responsible Personrelevant degree