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

Humand Talent; Oxford; On-site; GBP 60,000 - 80,000; Full time

Job summary

A forward-thinking medical device company in Oxford is seeking a Regulatory Affairs Manager to lead the global regulatory strategy. In this strategic role, you will manage international regulatory submissions, act as a liaison with regulatory bodies, and support technical documentation review while working on innovative technologies. The ideal candidate has significant experience in regulatory affairs, knowledge of EU MDR and FDA requirements, and strong communication skills. This opportunity blends autonomy and impact in a compliance-focused environment.

Qualifications

• Vast experience in regulatory affairs or compliance within the medical device environment.
• Solid grasp of EU MDR and FDA requirements.
• Experience managing Class IIa submissions.

Responsibilities

• Lead regulatory submissions and renewals across UK, EU, US, and international markets.
• Act as a key liaison with regulatory bodies and representatives.
• Support the creation of technical documentation to meet global standards.

Skills

Regulatory affairs experience

EU MDR knowledge

FDA requirements knowledge

Excellent communication skills

Document management skills

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.