Associate Director, Regulatory Legal Counsel

Illumina; Bardi; In loco; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Illumina seeks a senior Regulatory Legal Counsel to provide strategic legal guidance across the lifecycle of medical devices, diagnostics, and life-science products in EMEA and Latin America. The role collaborates with cross-functional teams to enable compliant product development, submission, and post-market activities in a fast-paced international setting.

The ideal candidate is a qualified lawyer with significant regulatory advisory experience in med tech or life sciences, fluent in English,

Competenze

• Must be a qualified lawyer in the UK, the United States, or an EU Member State.
• Significant regulatory advisory experience in medical devices, diagnostics, or life sciences.

Mansioni

• 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.
• Coordinate external counsel across jurisdictions as needed.

Conoscenze

Regulatory expertise

Cross-functional collaboration

English fluency

Formazione

Qualified lawyer

Descrizione del lavoro

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.

• bonus or variable compensation
• equity eligibility
• flexible time off
• private medical insurance (UK)
• pension contribution (UK, 10%)
• life moments support and family-friendly policies
• 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
• 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 como, lombardia, it