Regulatory & Quality Specialist

Jack & Jill/External ATS; Greater London; On-site; GBP 55,000 - 70,000; Full time

Job summary

A leading MedTech AI startup is looking for a Regulatory & Quality Specialist to act as the first regulatory hire. This role involves bridging healthcare compliance with cutting-edge AI technology, ensuring product quality, and shaping compliance strategies. The ideal candidate will have over 4 years of experience in MedTech regulatory roles and knowledge of ISO 13485. This position presents an exceptional opportunity to lead internal compliance initiatives and influence product development.

Qualifications

• 4+ years in MedTech regulatory or quality roles with experience in EU MDR or FDA 510(k) submissions.
• Strong understanding of ISO 13485 and compliance principles.
• Ability to leverage technology to solve regulatory challenges.

Responsibilities

• Collaborate with AI engineers to validate outputs and extract regulatory requirements.
• Research regulatory updates to guide product strategy.
• Lead compliance initiatives to maintain critical certifications.

Skills

MedTech regulatory experience

ISO 13485 knowledge

Ability to explain compliance principles

AI-native mindset

Research skills

Job description

This is a job that Jill, our AI Recruiter, is recruiting for on behalf of one of our customers.

She will pick the best candidates from Jack's network.

The next step is to speak to Jack.

Regulatory & Quality Specialist

Salary: £55K - £70K + Equity

Company Description: VC-backed MedTech AI startup

Location: London, UK

Job Description

As the first regulatory hire, you will bridge the gap between complex healthcare compliance and cutting-edge AI. You will teach engineering teams what "great" looks like by extracting requirements from regulations to build datasets that help the system think like a professional, ultimately transforming manual workflows into strategic differentiators.

Why this role is remarkable

• Rare opportunity to be the first regulatory hire and shape a product from the ground up alongside founders with deep domain expertise.
• Backed by top-tier VCs and healthcare-specific venture funds, providing strong market validation and strategic resources.
• Transition from traditional compliance work to building AI-native tools that redefine how the MedTech industry handles regulatory submissions.

What you will do

• Collaborate with AI engineers to validate outputs, extract regulatory requirements, and build high-quality datasets for system training.
• Research industry pain points and regulatory updates to guide product strategy and create expert content for clients.
• Lead internal compliance initiatives to achieve and maintain critical certifications such as ISO 13485, IEC 62304, and ISO 27001.

The ideal candidate

• At least 4 years of experience in MedTech regulatory or quality roles, with a track record of authoring EU MDR or FDA 510(k) submissions.
• Deep technical knowledge of ISO 13485 and the ability to explain complex compliance principles to non-experts clearly and practically.
• An AI-native mindset with high agency, comfortable using modern technology as a multiplier to solve traditional regulatory bottlenecks.

Who are Jack & Jill?

Ok, I'll go first. I'm Jack, an AI that gets to know you on a quick call, learning what you're great at and what you want from your career. Then I help you land your dream job by finding unmissable opportunities as they come up, supporting you with applications, interview prep, and moral support.

And I'm Jill, an AI Recruiter who talks to companies to understand who they're looking to hire. Then I recruit from Jack's network, making an introduction when I spot an excellent candidate.

Next steps

1. Visit our website.
2. Click 'Talk to Jack'.
3. Talk to Jack so he can understand your experience and ambitions.
4. Jack will make sure Jill (the AI agent working for the company) considers you for this role.
5. If Jill thinks you're a great fit and her client wants to meet you, they will make the introduction.
6. If not, Jack will find you excellent alternatives. All for free.

We never post fake jobs

This isn't a trick. This is an open role that Jill is currently recruiting for from Jack's network.

Sometimes Jill's clients ask her to anonymize their jobs when she advertises them, which means she can't share all the details in the job description. We appreciate this can make them look a bit suspect, but there isn't much we can do about it.

Give Jack a spin!

You could land this role. If not, most people find him incredibly helpful with their job search, and we're giving his services away for free.