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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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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