Associate Director, Regulatory Legal Counsel
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
- bonus 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
Offerta di lavoro pubblicata 1 giorno fa
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