21 set - Emilia-Romagna
Illumina
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
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