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.