Associate Director, Regulatory Legal Counsel
12 hours ago
Vitoria-Gasteiz
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 / Beneficios • bonus or variable compensation, • equity eligibility, • flexible time off, • private medical insurance (UK), • pension contribution (UK, 10%), • life moments support and family-friendly policies Responsabilidades • Provide regulatory legal advisory and strategy across EMEA and Latin America for medical devices, diagnostics, and life science products, • Interpret EU and UK medical device and IVD frameworks, country-specific requirements, and horizontal regulations, • Assess regulatory risk and support informed business decisions, • Support product lifecycle activities, submissions, market access strategies, and post-market obligations with Regulatory Affairs and Quality, • Advise on regulatory considerations for hardware, software, services, digital solutions, and AI-related requirements, • Support global and regional product lifecycle management, • Review product labeling, promotions, and external communications for regulatory compliance, • Collaborate with Commercial Legal, Compliance, Procurement, IT, and others to assess regulatory aspects in contracts and tenders, • Assist with inspection readiness, regulatory audits, recalls, field actions, and post-market responses, • Monitor regulatory developments and contribute to internal policies, training materials, and governance, • Coordinate external counsel across jurisdictions as needed Requisitos principales • Qualified lawyer in the UK, the United States, or an EU Member State, • Significant regulatory advisory experience in medical devices, med tech, biotechnology, or life sciences, • Prior in-house and/or law firm experience advising regulatory clients (preferred), • Full professional fluency in English; additional languages a plus, • Experience supporting business clients in regulated, international environments, • Experience 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 products, • Ability to work across time zones in a global organization, • Clear, confident communication, • Cross-functional collaboration, • Proactive and adaptable mindset, • Regulatory expertise for medical devices, diagnostics, and life sciences, • EU/UK medical device and IVD frameworks (IVDR), • Regulatory intelligence and trend analysis
Donostia San Sebastian Kalea, 01010, Vitoria-Gasteiz
