Director, Legal (Regulatory and Quality Counsel)

We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.

Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics.

Experience supporting a business unit within a med device, med tech, and/or life sciences company.

Familiarity with FDA Quality System Regulation (QSR), ISO 13485 and other international regulatory norms is desirable.

Experience advising on legal and regulatory matters in a matrixed, multinational environment.

The Director, Legal (Regulatory and Quality Counsel) will serve as a senior legal advisor within Illumina’s global legal regulatory practice, providing high-level legal support on complex regulatory matters impacting medical device, diagnostics, and RUO (Research Use Only) product lifecycle.

This position plays a critical role in enabling business objectives while ensuring compliance with applicable laws and regulatory frameworks, including the U.S.

Food, Drug, and Cosmetic Act (FDCA), FDA medical device regulations,  the European Union In Vitro Diagnostic Regulation (IVDR) and other similar regulations.

This position requires a hands-on, business-oriented, and solutions-focused legal professional with deep in-house experience, ideally within the med tech or biotechnology sector.

The Director will operate in a highly matrixed global environment, collaborating across Regulatory Affairs, Quality, Medical Affairs, Sales and Marketing, Global Compliance, and other cross-functional teams to proactively identify regulatory risks, provide strategic legal counsel, and shape Illumina’s engagement with regulators.

Provide expert legal guidance on U.S.