Posted 20 July, 2026

Regional Regulatory Affairs Lead

Jobtailor

Greater London, ENG, GB Full Time

\n Overview\n

Set up the EMEA Regulatory Affairs (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 UK Responsible Person (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.

Qualifications\n

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 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—experience planning and leading 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 judgment to distinguish what to automate from what requires expert oversight.
A degree in a relevant field.

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