Head of Regulatory Affairs

The Opportunity Hub UK Ltd; Leeds; Hybrid; GBP 46,000 - 67,000; Full time

Benefits offered by this job

Hybrid working

Private medical and dental insurance

Enhanced pension scheme

Performance-based bonuses

Job summary

The Opportunity Hub UK Ltd in Leeds is seeking an ambitious Head of Regulatory Affairs to drive compliant healthcare initiatives and strategic submissions across product lines.

Hybrid role based between home and Leeds office. You will lead a small team, liaise with MHRA, and ensure alignment with UK/EU frameworks. Competitive salary and enhanced pension.

Qualifications

• Solid grounding in UK healthcare regulatory requirements, ideally with MHRA exposure.
• Experience managing regulatory submissions from start to finish.
• Clear written communication for regulators and executives.
• Ability to lead and develop a small regulatory team.

Responsibilities

• Lead regulatory submissions and liaise with healthcare authorities.
• Build and maintain regulatory strategy across product lines for UK/EU frameworks.
• Review internal processes against current legislation and flag gaps.
• Manage a small team of regulatory specialists and set priorities.
• Represent regulatory affairs in cross-functional meetings with clinical, quality, and commercial teams.
• Track upcoming regulatory changes and brief senior leadership.

Skills

UK healthcare regulatory requirements

Regulatory submissions

Written communication

People management

Attention to detail

Independent working

Job description

Ambitious Head of Regulatory Affairs wanted to drive real impact in Healthcare from Leeds.

Healthcare regulation doesn't stand still. New compliance frameworks, tighter reporting standards and constant scrutiny mean the sector needs people who can stay ahead of change rather than just react to it. This role sits with an established enterprise healthcare provider, the kind of organisation with 250 plus staff, structured career paths and large-scale projects that actually move the needle. If you want your work to matter beyond a spreadsheet, this is that job.

Here's what you'll be doing:

• Lead regulatory submissions and liaise directly with healthcare authorities on approvals and compliance matters
• Build and maintain the regulatory strategy across product lines, keeping it aligned with UK and EU healthcare frameworks
• Review internal processes against current legislation and flag gaps before they become problems
• Manage a small team of regulatory specialists, setting priorities and reviewing their output
• Represent regulatory affairs in cross-functional meetings with clinical, quality and commercial teams
• Track upcoming regulatory changes and brief senior leadership on what they mean for the business

Here are the skills you'll need:

• Solid grounding in UK healthcare regulatory requirements, ideally with MHRA or equivalent exposure
• Experience managing regulatory submissions from start to finish, not just contributing to them
• Clear written communication. You'll be drafting documents that regulators and executives both need to understand
• Comfortable managing people and holding them to a standard
• Sharp attention to detail. Small errors in this field carry real consequences
• Ability to work independently within a structured, best-practice driven environment

Key perks and benefits:

• Salary of £46,000 to £66,500, depending on experience
• Hybrid working, with time split between home and the Leeds office
• Private medical and dental insurance
• Enhanced pension scheme and performance-based bonuses
• A full benefits package built for people who plan to stay

Why pursue a career in Healthcare?

Healthcare regulation is one of those fields that only grows more important. Every new treatment, device and data system needs someone who understands the rules and can apply them properly, and that expertise is in short supply. Leeds has become a genuine hub for healthcare and life sciences employers, so building a career here as Head of Regulatory Affairs puts you close to the action rather than on the sidelines of it.