Associate Director, Regulatory Legal Counsel

pIn this senior regulatory role, you provide strategic legal guidance across the lifecycle of Illumina’s medical devices, diagnostics, and life-science products in EMEA and Latin America. You collaborate with cross-functional teams to enable compliant product development, submission, and post-market activities in a fast-paced, international setting. You translate complex regulatory rules into actionable guidance for executives and product teams, helping balance compliance with innovation. You will contribute to a mission-driven environment focused on expanding access to genomic technology and improving health outcomes. /pullibonus or variable compensation /liliequity eligibility /liliflexible time off /liliprivate medical insurance (UK) /lilipension contribution (UK, 10%) /lililife moments support and family-friendly policies /liliProvide regulatory legal advisory and strategy across EMEA and Latin America for medical devices, diagnostics, and life science products /liliInterpret EU and UK medical device and IVD frameworks, country-specific requirements, and horizontal regulations /liliAssess regulatory risk and support informed business decisions /liliSupport product lifecycle activities, submissions, market access strategies, and post-market obligations with Regulatory Affairs and Quality /liliAdvise on regulatory considerations for hardware, software, services, digital solutions, and AI-related requirements /liliSupport global and regional product lifecycle management /liliReview product labeling, promotions, and external communications for regulatory compliance /liliCollaborate with Commercial Legal, Compliance, Procurement, IT, and others to assess regulatory aspects in contracts and tenders /liliAssist with inspection readiness, regulatory audits, recalls, field actions, and post-market responses /liliMonitor regulatory developments and contribute to internal policies, training materials, and governance /liliCoordinate external counsel across jurisdictions as needed /liliQualified lawyer in the UK, the United States, or an EU Member State /liliSignificant regulatory advisory experience in medical devices, med tech, biotechnology, or life sciences /liliPrior in-house and/or law firm experience advising regulatory clients (preferred) /liliFull professional fluency in English; additional languages a plus /liliExperience supporting business clients in regulated, international environments /liliExperience advising on EU and UK medical device and diagnostics frameworks, including IVDR (preferred) /liliExperience with post-market vigilance, inspections, and regulatory authority interactions (preferred) /liliExperience collaborating with commercial teams on regulated products /liliAbility to work across time zones in a global organization /liliClear, confident communication /liliCross-functional collaboration /liliProactive and adaptable mindset /liliRegulatory expertise for medical devices, diagnostics, and life sciences /liliEU/UK medical device and IVD frameworks (IVDR) /liliRegulatory intelligence and trend analysis /li /ul #J-18808-Ljbffr