Associate Director, Regulatory Legal Counsel

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

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