Illumina · 6 days ago
Director, Legal (Regulatory and Quality Counsel)
San Diego, CA
Full-time
Hybrid
Director/Executive
$225K/yr - $337K/yr
18+ years expIllumina is a company focused on expanding access to genomic technology to promote health equity. The Director, Legal (Regulatory and Quality Counsel) will provide high-level legal support on complex regulatory matters impacting medical devices and diagnostics, ensuring compliance with applicable laws and collaborating across various teams to mitigate regulatory risks.
BiotechnologyGeneticsHealth CareMedical
No H1B
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
Qualification
Required
Juris Doctor (JD) from an accredited law school
Licensed to practice law in at least one U.S. jurisdiction
Typically requires a Bachelor's degree and a minimum of 18 years of related experience, with 10+ years of Management experience
Extensive in-house counsel experience, preferably in the medical device, diagnostics, or biotechnology industry
Demonstrated expertise in FDA regulatory matters and related U.S. legal frameworks
Experience advising on EU regulatory frameworks, including IVDR
Strong familiarity with legal support for business unit operations in a scientific/regulated environment
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 guidance in the context of commercial goals, clinical strategy, and product timelines
Matrix Collaboration: Skilled at navigating global, cross-functional environments and influencing diverse stakeholders
Leadership: Proven ability to lead, mentor and develop legal professionals
Executive Communication: Communicates effectively with senior leaders and regulators
Resilience and Agility: Thrives in a fast-paced environment while maintaining compliance rigor
Flexible to work across multiple time zones to support global stakeholders
Domestic and international travel may be required; anticipated travel is less than 10%
Willingness to be based in or travel regularly to San Diego, with a hybrid schedule preferred
Preferred
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
Law firm experience is preferred but not required
Experience advising on legal and regulatory matters in a matrixed, multinational environment
Benefits
Access to genomics sequencing
Family planning
Health/dental/vision
Retirement benefits
Paid time off
Company
Illumina
Illumina is an innovative technology and revolutionary assays aiming the analyze genetic variation and function.
5001-10000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.28BKey Investors
Bank of America
2024-09-06Post Ipo Debt· $500M
2023-01-04Post Ipo Debt· $750M
2000-07-28IPO
Leadership Team
Steven Barnard
Chief Technology Officer, Head of Research & Product Development
Jenny Lei Zheng
SVP & GM of Greater China
Recent News
2026-01-22
2026-01-20
Company data provided by crunchbase