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

Humand Talent
Oxfordshire
2 days ago
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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.

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

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