Senior Regulatory Affairs Specialist

The Opportunity Hub UK Ltd; Reading; Hybrid; GBP 50,000 - 75,000; Full time

Benefits offered by this job

Equity in the business

Learning and development budget

Hybrid working from Reading

Job summary

The Opportunity Hub UK Ltd in Reading is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions, liaise with UK and EU authorities, and shape the regulatory strategy for new healthcare products. You will review documentation, ensure compliant labelling, and work with quality, clinical, and commercial teams to keep launches on track.

You will navigate UK MHRA and EU MDR/IVDR frameworks with precision, communicate changes clearly, and drive post-market surveillance to

Qualifications

• Experience in regulatory affairs within healthcare, medtech or pharmaceuticals.
• Working knowledge of UK MHRA and EU MDR/IVDR frameworks.
• Sharp attention to detail with minimal room for guesswork.
• Comfort communicating with regulators, auditors and internal stakeholders.
• Able to thrive in a startup where priorities shift and you wear multiple hats.

Responsibilities

• Lead regulatory submissions and liaise directly with UK and EU regulatory bodies on product approvals.
• Review technical documentation, labelling and clinical evidence for compliance before release.
• Build and maintain regulatory strategy for new product launches from development to market.
• Track regulatory changes and translate them into practical actions for the team.
• Collaborate with quality, clinical and commercial functions to avoid delays at the regulatory stage.
• Own post-market surveillance reporting and flag risks early.

Skills

Regulatory affairs

UK MHRA & EU MDR/IVDR

Attention to detail

Regulator communication

Startup environment adaptability

Education

Life sciences degree

Job description

Perfect role for a senior professional looking to grow their Healthcare career in Reading.

Regulatory affairs sits at the sharp end of Healthcare right now. Approval timelines are tightening, post-market scrutiny is increasing, and a fast-moving healthcare startup based in Reading needs someone who can keep products compliant without slowing down the pace of the business. This Senior Regulatory Affairs Specialist role sits right at that intersection: enough autonomy to shape process, enough scale to make a genuine dent in outcomes.

Here's what you'll be doing:

Leading regulatory submissions and liaising directly with UK and EU regulatory bodies on product approvals

Reviewing technical documentation, labelling and clinical evidence for compliance before anything goes out the door

Building and maintaining regulatory strategy for new product launches, from early development through to market

Tracking changes in Healthcare regulation and translating them into practical actions for the wider team

Working closely with quality, clinical and commercial teams so nothing gets held up at the regulatory stage

Owning post-market surveillance reporting and flagging risk before it becomes a problem

Here are the skills you'll need:

Solid experience in a regulatory affairs role within Healthcare, medtech or pharmaceuticals

Working knowledge of UK MHRA and EU MDR/IVDR frameworks

Sharp attention to detail. Regulatory work leaves no room for guesswork

Confidence communicating with regulators, auditors and internal stakeholders in equal measure

Comfort operating in a startup environment where priorities shift and you'll wear more than one hat

A degree in life sciences, pharmacy or a related field is preferred but not the only route in

Key perks and benefits:

£50,000 to £74,500, depending on experience

Equity in the business. You'll have a genuine stake in what you're helping to build

Hybrid working from the Reading office, with flexible hours around it

Learning and development budget to keep your regulatory knowledge current

Flat structure. You'll have direct access to leadership, not layers of sign-off

Why pursue a career in Healthcare?

Healthcare regulation isn't going anywhere. If anything, it's getting more complex, which means specialists who understand it well are becoming harder to find and better rewarded. Reading has quietly become a strong base for Healthcare and life sciences activity, with good transport links and a growing cluster of companies in the space. A Senior Regulatory Affairs Specialist who builds their reputation here has real room to progress, whether that's deeper into regulatory strategy or across into broader compliance leadership.