Regulatory Affairs Specialist - ID45000 - Up to £60k DOE in Oxfordshire

Job description

Ready to lead global regulatory strategy?

Want to shape compliance for innovative medical technologies?

Looking for flexibility, ownership, and international impact?

A forward-thinking medical device company is seeking a Regulatory Affairs Manager to join its Quality and Compliance function, playing a pivotal role in managing global regulatory approvals across both established and emerging markets.

This is an exciting opportunity to take ownership of international regulatory submissions, collaborate with cross-functional teams, and influence strategic direction — all within a business delivering life-enhancing technologies.

Why This Role is Great

As Regulatory Affairs Manager, you'll enjoy:

• Leading regulatory submissions and renewals across the UK, EU, US, and international markets.
• Acting as a key liaison with regulatory bodies, notified bodies, and in-country representatives.
• Supporting the creation and review of technical documentation that meets evolving global standards.
• Contributing to post-market surveillance, audits, and strategic compliance initiatives.
• Helping shape future market access plans in partnership with commercial and product teams.

This role offers a mix of autonomy, influence, and hands-on technical engagement — ideal for someone looking to step into a strategic role without losing touch with the detail.

About You

This opportunity is perfect for someone who wants to work with a range of innovative technologies — from electromechanical devices to integrated software systems — and play a lead role in global regulatory operations.

You’ll likely bring:

• Vast Experience in regulatory affairs or compliance within a medical device environment.
• A solid grasp of EU MDR (and legacy MDD), FDA requirements, and international submission processes.
• Experience managing Class IIa submissions and contributing to Technical Files.
• Confidence working across both medical and non-medical regulatory frameworks (e.g. Low voltage, EMC).
• Excellent communication, document management, and cross-functional collaboration skills.

Extra information

Status

Closed

Education Level

Secondary School

Location

Oxfordshire

Type of Contract

Part-time jobs

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English