Senior Attorney, Legal

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.

Requirements

• 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.

Benefits

• Health/dental/vision
• Retirement benefits
• Paid time off
• Family planning