Associate Director, Regulatory Legal Counsel

Illumina, Inc.; Napoli; On-site; EUR 90,000 - 140,000; Full time

Benefits offered by this job

Bonus pay

Equity eligibility

Flexible time off

Private medical insurance

Pension contribution

Life events support

Family-friendly policies

Job summary

Illumina seeks a senior regulatory legal counsel in Napoli, Campania, to guide the lifecycle of medical devices, diagnostics, and life-science products across EMEA and Latin America. You translate complex regulatory rules into actionable guidance for executives and product teams, balancing compliance with innovation.

You will collaborate across functions, review labeling and communications for regulatory adequacy, coordinate with external counsel, and support global product lifecycle management

Qualifications

• Significant regulatory advisory experience in medical devices, med tech, biotechnology, or life sciences.
• In-house and/or law firm experience advising regulatory clients preferred.
• Full professional fluency in English; additional languages a plus.

Responsibilities

• 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.
• 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.

Skills

Regulatory law expertise

Cross-functional collaboration

Strong communication

Global time-zone coordination

English fluency

Education

Law degree

Job description

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 napoli, campania, it