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.
/p ul libonus or variable compensation /li liequity eligibility /li liflexible time off /li liprivate medical insurance (UK) /li lipension contribution (UK, 10%) /li lilife moments support and family-friendly policies /li liProvide regulatory legal advisory and strategy across EMEA and Latin America for medical devices, diagnostics, and life science products /li liInterpret EU and UK medical device and IVD frameworks, country-specific requirements, and horizontal regulations /li liAssess regulatory risk and support informed business decisions /li liSupport product lifecycle activities, submissions, market access strategies, and post-market obligations with Regulatory Affairs and Quality /li liAdvise on regulatory considerations for hardware, software, services, digital solutions, and AI-related requirements /li liSupport global and regional product lifecycle management /li liReview product labeling, promotions,



and external communications for regulatory compliance /li liCollaborate with Commercial Legal, Compliance, Procurement, IT, and others to assess regulatory aspects in contracts and tenders /li liAssist with inspection readiness, regulatory audits, recalls, field actions, and post-market responses /liliMonitor regulatory developments and contribute to internal policies, training materials, and governance /li liCoordinate external counsel across jurisdictions as needed /li liQualified lawyer in the UK, the United States, or an EU Member State /li liSignificant regulatory advisory experience in medical devices, med tech, biotechnology, or life sciences /li liPrior in-house and/or law firm experience advising regulatory clients (preferred) /li liFull professional fluency in English; additional languages a plus /li liExperience supporting business clients in regulated, international environments /li liExperience advising on EU and UK medical device and diagnostics frameworks, including IVDR (preferred) /li liExperience with post-market vigilance, inspections, and regulatory authority interactions (preferred) /li liExperience collaborating with commercial teams on regulated products /li liAbility to work across time zones in a global organization /li liClear, confident communication /li liCross-functional collaboration /li liProactive and adaptable mindset /li liRegulatory expertise for medical devices, diagnostics, and life sciences /li liEU/UK medical device and IVD frameworks (IVDR) /li liRegulatory intelligence and trend analysis /li /ul pAssociate Director, Regulatory Legal Counsel napoli, campania, it /p #J-*****-Ljbffr

📌 Associate Director, Regulatory Legal Counsel (Napoli)
🏢 Illumina
📍 Napoli