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Regulatory Affairs Manager (IVD)

Arevna
Cambridge
1 month ago
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Arevna Cambridge, England, United Kingdom

Regulatory Affairs Manager (IVD)

Arevna Cambridge, England, United Kingdom

2 days ago Be among the first 25 applicants

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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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We’re not including extraneous postings or site notices in this refined description. For full details, please refer to the original listing.


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