Descripción de la oferta
Overview
In 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.
Compensaciones / Beneficiosbonus or variable compensationequity eligibilityflexible time offprivate medical insurance (UK)pension contribution (UK, 10%)life moments support and family-friendly policies
ResponsabilidadesProvide regulatory legal advisory and strategy across EMEA and Latin America for medical devices, diagnostics, and life science productsInterpret EU and UK medical device and IVD frameworks, country-specific requirements, and horizontal regulationsAssess regulatory risk and support informed business decisionsSupport product lifecycle activities, submissions, market access strategies, and post-market obligations with Regulatory Affairs and QualityAdvise on regulatory considerations for hardware, software, services, digital solutions, and AI-related requirementsSupport global and regional product lifecycle managementReview product labeling, promotions, and external communications for regulatory complianceCollaborate with Commercial Legal, Compliance, Procurement, IT, and others to assess regulatory aspects in contracts and tendersAssist with inspection readiness, regulatory audits, recalls, field actions, and post-market responsesMonitor regulatory developments and contribute to internal policies, training materials, and governanceCoordinate external counsel across jurisdictions as needed
Requisitos principalesQualified lawyer in the UK, the United States, or an EU Member StateSignificant regulatory advisory experience in medical devices, med tech, biotechnology, or life sciencesPrior in-house and/or law firm experience advising regulatory clients (preferred)Full professional fluency in English; additional languages a plusExperience supporting business clients in regulated, international environmentsExperience advising on EU and UK medical device and diagnostics frameworks, including IVDR (preferred)Experience with post-market vigilance, inspections, and regulatory authority interactions (preferred)Experience collaborating with commercial teams on regulated productsAbility to work across time zones in a global organizationClear, confident communicationCross-functional collaborationProactive and adaptable mindsetRegulatory expertise for medical devices, diagnostics, and life sciencesEU/UK medical device and IVD frameworks (IVDR)Regulatory intelligence and trend analysis
