Associate Director, Regulatory Legal Counsel

Over de vacature

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.

Arbeidsvoorwaarden / 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

Verantwoordelijkheden

• 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

Belangrijkste vereisten

• 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

Advertentie Cv voorbeelden voor Juridisch & Wetgeving: zo ziet een sterk cv eruit Bekijk het voorbeeld en maak je eigen versie. Bekijk voorbeeld Geen account nodig