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.

Retribuzione / Benefits premio or variable compensation equity eligibility flexible time off private medical insurance (UK) pension contribution (UK, 10%) life moments support and family-friendly policies Responsabilità 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 Requisiti fondamentali 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

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