06 oct
|
Illumina
|
Gerona
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 general 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 Qu
📌 Associate Director, Regulatory Legal Counsel (Gerona)
🏢 Illumina
📍 Gerona