Regulatory Affairs Manager

The Opportunity Hub UK Ltd; City of Edinburgh; Hybrid; GBP 48,000 - 70,000; Full time

Benefits offered by this job

Equity

Hybrid work

Learning budget

Remote-friendly culture

Job summary

The Opportunity Hub UK Ltd in Edinburgh is seeking a Regulatory Affairs Manager to lead regulatory submissions, liaise with MHRA, and shape regulatory strategy from concept to launch.

You will review technical files, advise product teams on regulatory risk, and track legislative changes to translate them into actionable tasks. Based in Edinburgh with hybrid working and a strong learning culture.

Qualifications

• Solid experience in a regulatory affairs role within healthcare, medical devices or life sciences.
• Working knowledge of UK MDR, EU MDR or equivalent regulatory frameworks.
• Comfortable writing clearly under pressure. Regulatory documents don't forgive vague language.
• The confidence to challenge a founder or product lead when the regulatory risk is real.
• A degree in a relevant scientific, medical or regulatory field.
• Genuine curiosity about how healthcare products actually get to market.

Responsibilities

• Leading regulatory submissions and liaising directly with bodies such as the MHRA, ensuring products meet UK and international healthcare standards.
• Building and maintaining regulatory strategy documents that guide product development from concept through to launch.
• Reviewing technical files, labelling and clinical evaluation reports for accuracy and compliance.
• Advising commercial and product teams on regulatory risk before decisions get made, not after.
• Tracking changes in healthcare legislation and translating them into practical actions for the business.
• Managing relationships with external notified bodies, consultants and auditors.

Skills

Healthcare regulatory experience

UK MDR / EU MDR knowledge

Clear writing under pressure

Ability to push back on founders

Relevant scientific/regulatory degree

Curiosity about getting products to市場

Education

Degree in scientific/medical/regulatory field

Job description

Make your mark as a Regulatory Affairs Manager in the Healthcare sector, based in Edinburgh.

Healthcare regulation in the UK has tightened considerably over the past few years, and startups building new diagnostics, devices or digital health tools feel that pressure first. This growing healthcare business, based in Edinburgh, needs someone who can turn regulatory complexity into a competitive advantage rather than a bottleneck. It's a small team with big ambitions, and the person in this Regulatory Affairs Manager role will shape how the company approaches compliance from the ground up.

Here’s what you'll be doing:

Leading regulatory submissions and liaising directly with bodies such as the MHRA, ensuring products meet UK and international healthcare standards

Building and maintaining regulatory strategy documents that guide product development from concept through to launch

Reviewing technical files, labelling and clinical evaluation reports for accuracy and compliance

Advising commercial and product teams on regulatory risk before decisions get made, not after

Tracking changes in healthcare legislation and translating them into practical actions for the business

Managing relationships with external notified bodies, consultants and auditors

Here are the skills you'll need:

Solid experience in a regulatory affairs role within healthcare, medical devices or life sciences

Working knowledge of UK MDR, EU MDR or equivalent regulatory frameworks

Comfortable writing clearly under pressure. Regulatory documents don't forgive vague language

The confidence to challenge a founder or product lead when the regulatory risk is real

A degree in a relevant scientific, medical or regulatory field

Genuine curiosity about how healthcare products actually get to market

Key perks and benefits:

£47,500 to £70,000, depending on experience

Equity in a business that's still early enough for it to mean something

Hybrid working from the Edinburgh base, with flexible hours around it

A proper learning and development budget, not just a line on a benefits sheet

Remote-friendly culture and a flat structure where your input actually reaches decision-makers

Why pursue a career in Healthcare?

Healthcare rewards people who take regulation seriously, because getting it wrong costs lives, not just money. Edinburgh has quietly become one of the UK's stronger hubs for health tech and life sciences, with a growing cluster of startups that need exactly this kind of expertise. A good Regulatory Affairs Manager rarely struggles for work, and the path from here into senior compliance or even director-level roles is well worn.