Regional Regulatory Affairs Lead

Job Description

Overview

• 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

• 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.