Illumina · 1 month ago
Senior Attorney, Legal
US - California - San Diego
Full-time
Onsite
Senior Level, Lead/Staff
$184K/yr - $276K/yr
10+ years expIllumina is a company focused on expanding access to genomic technology for health equity. The Senior Attorney, Legal will provide specialized legal support in regulatory matters, ensuring compliance with FDA and international requirements while collaborating with various internal teams.
BiotechnologyGeneticsHealth CareMedical
No H1B
Responsibilities
Provide legal guidance on U.S. and international medical device, diagnostic, and life science regulatory requirements, including the FDCA, FDA regulations, and the EU In Vitro Diagnostic Regulation (IVDR)
Partner with Regulatory Affairs and Quality to support product submissions, market access strategies, and post-market regulatory obligations
Review and advise on product labeling, promotional materials, and communications to ensure regulatory compliance and mitigate risk
Support inspection readiness and regulatory audits, including responses to inquiries from the FDA and other global regulatory authorities
Collaborate cross-functionally to assess regulatory risks in contracts, quality agreements, and business transactions
Conduct legal research and analysis on evolving global regulatory trends and emerging requirements
Assist with preparation of internal policies, procedures, and training to support regulatory compliance and inspection readiness
Draft and review correspondence and documentation for regulatory submissions and responses
Coordinate with Commercial Legal, Compliance, and Corporate Development teams on matters involving regulatory considerations
Engage with external counsel as needed to support specialized regulatory matters in foreign jurisdictions
Qualification
Required
Juris Doctor (JD) from an accredited law school
Licensed to practice law in at least one U.S. jurisdiction
Typically requires 10–12 years of legal practice, including 6–8 years of in-house or directly relevant experience in the medical device, diagnostics, or biotechnology industry, or an equivalent combination of education and experience
Strong knowledge of U.S. FDA regulatory frameworks and related post-market requirements
Experience supporting business clients in a regulated environment
Preferred
Prior in-house counsel experience in medical device, med tech, or life sciences organizations
Familiarity with FDA Quality System Regulation (QSR), ISO 13485, and international regulatory requirements
Law firm experience supporting regulatory clients preferred
Experience advising on global product development and lifecycle management
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