Associate Director, Regulatory Legal Counsel (EMEA & Latin America)

About the Role As Associate Director, Regulatory Legal Counsel (EMEA & Latin America) at Illumina, you will be a key member of Illumina’s global Regulatory Legal team, 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. You will partner closely with Regulatory Affairs, Quality, Medical Affairs, Global Compliance, Commercial, Marketing, and other cross‑functional stakeholders to enable compliant product development, commercialization, and post‑market activities across Europe, the Middle East, Africa, and Latin America. What You'll Do

• Provide regulatory legal guidance on regulatory requirements across EMEA and Latin America for medical devices, diagnostics, and life science products.
• Interpret and advise on EU and UK medical device and IVD regulatory frameworks, country-specific requirements, and horizontal regulations impacting the sector.
• Assess regulatory risk across diverse jurisdictions and support informed business decision-making.
• Partner with Regulatory Affairs and Quality to support product development, regional and global submissions, market access strategies, and post-market obligations.
• Advise on regulatory considerations for hardware, software, services, digital solutions, and emerging technologies, including AI-related regulatory requirements.
• Support global and regional product lifecycle management activities.
• Review and advise on product labeling, promotional and marketing materials, and external communications to ensure regulatory compliance.
• Collaborate with Commercial Legal, Compliance, Procurement, IT, and other stakeholders to assess regulatory considerations in contracts, tenders, licensing, distribution, R&D, and procurement activities.
• Support inspection readiness, regulatory audits, and post‑market vigilance activities; advise on recalls, field actions, and post‑market corrective actions.
• Prepare responses to inquiries, inspections, and communications from regional and country‑specific regulatory authorities.
• Monitor and analyze evolving regulatory developments and trends across EMEA and Latin America; assist with internal policy, SOP, and training material development; deliver regulatory legal training.
• Coordinate and manage engagement with external counsel in foreign jurisdictions, as required. What We're Looking For
• Qualified lawyer in the UK, the United States, or an EU Member State.
• Significant experience in a regulatory advisory role within the medical device, med tech, biotechnology, or life sciences sector.
• Prior in‑house and/or law firm experience advising regulatory clients preferred.
• Full professional fluency in English; additional languages are a plus.
• Demonstrated ability to support business clients in regulated, international environments.
• Experience collaborating with cross‑functional teams including regulatory, quality, medical, and commercial. Preferred Credentials
• Experience advising on EU and UK medical device and diagnostics regulatory frameworks, including IVDR.
• Familiarity with post‑market vigilance, inspections, and regulatory authority interactions.
• Experience supporting global or regional product development and lifecycle management.
• Experience working closely with commercial teams on regulated products. Nice to Have
• Optional/preferred qualifications (as mentioned in the posting): familiarity with AI-related regulatory considerations, cross‑jurisdictional regulatory regimes, and translating complex regulatory requirements into business‑friendly guidance. Compensation & Benefits
• Illumina's employee benefits are industry‑leading and include flexible time off, private medical insurance, compassion and care time off, leisure travel insurance, pension, employee stock purchasing program, volunteer time off, and much more. Location in the London/Cambridge area preferred. About Illumina Illumina, Inc. is expanding access to genomic technology to realize health equity for billions of people worldwide. This role supports a fast‑paced, matrixed environment that drives innovative solutions in medical devices and diagnostics to improve human health.