Regulatory Affairs Manager (IVD)

Arevna Cambridge, England, United Kingdom

Regulatory Affairs Manager (IVD)

Arevna Cambridge, England, United Kingdom

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Overview

Arevna is partnering with a pioneering life sciences organisation to recruit a Regulatory Affairs Manager to join their Cambridge-based Regulatory & Medical Affairs function. This team ensures products are safe, effective, and globally compliant, enabling market access for cutting-edge technologies. You will take ownership of regulatory strategy and execution across the full product lifecycle, from pre-market submissions to post-market surveillance, vigilance, and recalls. You’ll also lead and mentor a team while partnering cross-functionally to shape regulatory pathways for innovative product development.

What you’ll be doing

• Lead the design and delivery of regulatory strategies to support new product launches, updates, and market expansion.
• Serve as the regulatory lead and SME within cross-functional development teams, providing solution-focused guidance.
• Manage submissions, approvals, and regulatory interactions globally, ensuring timelines and compliance are met.
• Oversee post-market activities including vigilance, recalls, risk management, and product surveillance.
• Review and approve labelling, promotional materials, and technical documentation in line with international standards.
• Maintain compliance with ISO 13485 and other applicable frameworks, monitoring legislative changes and driving QMS alignment.
• Develop junior talent within the Regulatory Affairs function, building capability and ensuring best practice.
• Act as PRRC under IVDR (EU 2017/746) where designated.

What we’re looking for

• Degree (or equivalent) in life sciences.
• 5+ years’ experience in IVD and/or medical device regulatory affairs, ideally with EU focus.
• Recognised qualification in Regulatory Affairs and evidence of CPD.
• Strong knowledge of ISO 13485, with the ability to manage multiple projects and priorities.
• Desirable: global IVD expertise including 21 CFR Part 820, experience in post-market activities, and direct engagement with Competent Authorities or notified bodies.

What’s on offer

• Competitive salary package.
• 10% non-contributory pension.
• Group life assurance & income protection.
• 25 days annual leave plus UK bank holidays.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance and Administrative
• Industries: Medical Equipment Manufacturing

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