Director, Legal (Regulatory and Quality Counsel)

What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. Position Summary 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. Essential Duties and Responsibilities Provide expert legal guidance on U.S. and international medical device regulations applicable to Illumina’s research, diagnostic, and life sciences businesses. Serve as the lead legal advisor to Regulatory Affairs and Quality on product development, commercialization, post-market regulatory obligations, and global submissions. Analyze evolving global regulatory requirements and assess their impact on product strategy, labeling, promotional materials, and market access. Acts as a key partner and legal advisor to Sales and Marketing teams across all business units. Develop and execute legal strategy for major regulatory initiatives, ensuring alignment with internal stakeholders and global regulators. Deliver legal risk assessments with practical recommendations and risk mitigation strategies. Advise on inspection readiness and regulatory audits, including interactions with U.S. FDA and other global authorities. Participate in preparing responses to regulatory inquiries and inspections and providing guidance on post-market vigilance strategies, support related communication strategy and documentation. Oversee engagement with external counsel in foreign jurisdictions as needed. Collaborate with Commercial Legal on contract terms involving regulatory risks, including on issues of quality and post-market obligations. Advise Business Development team on regulatory issues surrounding strategic collaborations with industry partners, including product development, distribution, and co-marketing. Provide training and legal updates to functional teams on key regulatory developments. Engage cross-functionally to support standard operating procedures (SOPs), internal policy updates, and regulatory process improvements. Key Competencies Regulatory Law Expertise: Deep knowledge of the Food, Drug and Cosmetics Act, and implementing regulations, the EU IVDR, and similar regulatory frameworks in other global jurisdictions. Strategic Judgment: Ability to assess risk, anticipate regulatory changes, and develop business-aligned legal solutions. Business-Oriented: Understands how to deliver legal ... (truncated, view full listing at source)