Neko Health
Regional Regulatory Affairs Lead, EMEA
Part remote, part office, you need to live within commuting distance of a named location.
Hybrid · London
Employer listed it 3 months ago · Added yesterday
Been open since 3 months ago. Long-running listings are sometimes left up after the role is filled.
Salary
Not stated
Location
Hybrid · London
Timezone
Not stated
Contract
Full-time
Experience
Lead
Category
Other
This employer didn't state pay. Jobs like this usually pay around $175k–$255k a year, a typical range taken from 218 lead-level other roles on Nomaders that do state pay. It's a guide, not an offer.
Remote flexibility
Hybrid
This role is only partly remote, the employer expects time in the office around London, Hybrid, so you need to live within commuting distance.
What the employer says
- Source listing states candidate location: "London, Hybrid"
- Listing mentions "Hybrid"
What Nomaders makes of it
- Not suitable if you plan to move between countries
The quotes above are the employer's own words; the reading is ours. Always check the original listing and employment terms before working from another country.
About the role
Mission
Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear. In a single, non-invasive visit under an hour, proprietary technology and direct clinical care combine to deliver personalised, actionable insights. It's a team that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is the norm, and where your work genuinely helps people live longer, healthier lives.
As we grow across EMEA, we're looking for a regulatory leader to build our regulatory function for the region, based in the UK.
About the role
This is our first regulatory affairs hire in the UK. You'll build the EMEA RA function from the ground up, manage our relationship with the MHRA, and hold the role of UK Responsible Person. Working with the Director of Regulatory Affairs, you'll help shape Neko's global regulatory strategy and bring the EMEA perspective to the table.
Where you'll make an 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.
What you'll bring
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.
Nice to have
• Software as a Medical Device (SaMD) experience alongside a hardware device background.
• Experience partnering with product development in medtech or healthtech engineering.
• Experience building or scaling a regional regulatory team.
Requirements
- ·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.
Benefits
No benefits package published with this listing. Ask about it at first interview.
How to apply
- 1Check the flexibility label above, hybrid, matches where you plan to live and work.
- 2Tailor your CV to the role at Neko Health, mentioning your remote working experience.
- 3Apply directly on the employer's careers page using the button below. Nomaders never handles your application.
Found 1d ago. Last checked today. Always confirm the details on the original posting, salary and location can change after publication.
Listing sourced from Company boards.
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