Regulatory Affairs Specialist

Humand Talent; England; On-site; GBP 65,000 - 85,000; Full time

Job summary

A forward-thinking medical device company in the United Kingdom is looking for an experienced Regulatory Affairs Manager. This pivotal role involves managing global regulatory approvals and submissions across established and emerging markets. The successful candidate will work closely with various teams, liaise with regulatory bodies, and shape strategic compliance initiatives to ensure market access for innovative medical technologies. This is a unique opportunity for those looking to make an international impact in the regulatory field.

Qualifications

• Experience in regulatory affairs within the medical device industry.
• Strong understanding of global regulatory requirements.
• Excellent communication skills to liaise with multiple stakeholders.

Responsibilities

• Lead regulatory submissions and renewals across various international markets.
• Act as liaison with regulatory bodies and ensure compliance.
• Contribute to audits and strategic compliance initiatives.

Job description

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 ...