Regulatory Affairs Manager

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.

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