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Associate Director, Regulatory Legal Counsel (EMEA & Latin America)
I
Organising Institution / Firm
Not Specified by Organiser
Cambridge, England, United Kingdom (Hybrid)
Not Specified
Qualified lawyer in the UK, US, or EU with significant regulatory advisory experience in medical devices, med tech, biotech, or life sciences.
Job
Full Opportunity Brief
Title: Associate Director, Regulatory Legal Counsel (EMEA & Latin America)
Category: Jobs
Organiser: Illumina
Location: Cambridge, England, United Kingdom (Hybrid)
Eligibility: Qualified lawyer in the UK, US, or EU with significant regulatory advisory experience in medical devices, med tech, biotech, or life sciences.
Deadline: Not specified
Fees: None
Description: Illumina is seeking an Associate Director, Regulatory Legal Counsel for EMEA & Latin America. This hybrid role based in Cambridge, UK, involves providing strategic and pragmatic legal advice across the full lifecycle of Illumina's technologies and medical technology products, including research use only (RUO) and clinical offerings. The counsel will partner closely with Regulatory Affairs, Quality, Medical Affairs, Global Compliance, and Commercial teams to translate complex, multi-jurisdictional regulatory frameworks into business-focused legal guidance.
Key Responsibilities:
- Provide legal guidance on regulatory requirements for medical devices, diagnostics, and life science products across EMEA and Latin America.
- Interpret EU and UK medical device and IVD regulatory frameworks (including IVDR).
- Support product development, regional/global submissions, market access, and post-market obligations.
- Review product labeling, promotional materials, and external communications for compliance.
- Support inspection readiness, regulatory audits, and post-market vigilance.
Contact Email: accommodations@illumina.com (for accommodation requests)
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Associate Director, Regulatory Legal Counsel (EMEA & Latin America) in Cambridge employer: Illumina
At Illumina, we are dedicated to transforming human health through genomic technology, making us an exceptional employer for those passionate about scientific discovery. Our Cambridge location fosters a collaborative work culture, offering industry-leading benefits such as flexible time off, private medical insurance, and a strong commitment to employee growth and inclusivity. Join us to be part of a mission-driven team where your contributions can make a meaningful impact on the lives of billions.