Global Regulatory Counsel, MedTech & Life Sciences

Illumina

Cambridge

On-site

GBP 90,000 - 130,000

Full time

2 days ago

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Job summary

Illumina in the United Kingdom seeks an Associate Director, Regulatory Legal Counsel for EMEA & Latin America to provide strategic regulatory guidance across medical devices, diagnostics, and life sciences products. You will partner with Regulatory Affairs, Quality, Medical Affairs, Compliance, Commercial, and Legal teams to enable compliant product development and post-market activities.

The role requires UK/US/EU qualification, in-house experience, and ability to navigate multi-jurisdictional

Qualifications

Qualified UK/US/EU lawyer with regulatory expertise in medical devices or life sciences.
Significant in-house or regulatory advisory experience.
Experience with EU/UK medical device and IVD frameworks.

Responsibilities

Regulatory Advisory & Strategy: Provide regulatory guidance on EU/UK medical device and IVD frameworks across EMEA and LATAM; assess risk and support business decisions.
Product Lifecycle & Market Support: Advise on regulatory considerations for product development, submissions, market access, and post-market obligations.
Commercial, Marketing & Contractual Support: Review labeling, promotional materials, and contracts for regulatory compliance.
Post-Market, Inspections & Regulatory Interactions: Prepare for audits, recalls, and post-market actions; respond to authorities.
Regulatory Intelligence, Training & Governance: Monitor developments and provide training and SOP updates.