Senior Attorney, Legal

The Senior Attorney, Legal (Regulatory and Quality Counsel) at Illumina provides specialized legal support within the global regulatory legal practice. This role involves advising on regulatory and quality matters affecting the full lifecycle of Illumina’s medical device, diagnostics, and research use only (RUO) products. The attorney will partner with Regulatory Affairs, Quality, Medical Affairs, Global Compliance, and Commercial functions to deliver business-focused legal advice, ensuring compliance with U.S. FDA and international regulatory requirements. Key responsibilities include interpreting complex regulatory frameworks for product development, labeling, marketing, and post-market activities.

Must Have

• Provide legal guidance on U.S. and international medical device, diagnostic, and life science regulatory requirements.
• Partner with Regulatory Affairs and Quality to support product submissions and market access strategies.
• Review and advise on product labeling, promotional materials, and communications for regulatory compliance.
• Support inspection readiness and regulatory audits, including responses to inquiries from authorities.
• Collaborate cross-functionally to assess regulatory risks in contracts and business transactions.
• Conduct legal research and analysis on evolving global regulatory trends.
• Assist with preparation of internal policies, procedures, and training for compliance.
• Draft and review correspondence and documentation for regulatory submissions.
• Coordinate with Commercial Legal, Compliance, and Corporate Development teams.
• Engage with external counsel for specialized regulatory matters.
• Juris Doctor (JD) from an accredited law school.
• Licensed to practice law in at least one U.S. jurisdiction.
• Minimum 5-12 years of related experience.
• Strong knowledge of U.S. FDA regulatory frameworks.
• Experience supporting business clients in a regulated environment.

Good to Have

• Prior in-house counsel experience in medical device, med tech, or life sciences organizations.
• Familiarity with FDA Quality System Regulation (QSR) and ISO 13485.
• Law firm experience supporting regulatory clients.
• Experience advising on global product development and lifecycle management.

Perks & Benefits

• Access to genomics sequencing
• Family planning benefits
• Health/dental/vision insurance
• Retirement benefits
• Paid time off
• Variable cash programs (bonus or commission)
• Equity (for eligible roles)
• Inclusive environment
• Employee Resource Groups (ERG)
• Zero-net gap in pay regardless of gender, ethnicity, or race

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.

The Senior Attorney, Legal (Regulatory and Quality Counsel) will provide specialized legal support within Illumina’s global regulatory legal practice, advising on regulatory and quality matters affecting the full lifecycle of Illumina’s medical device, diagnostics, and research use only (RUO) products.

This role partners closely with Regulatory Affairs, Quality, Medical Affairs, Global Compliance, and Commercial functions to deliver clear, business-focused legal advice that ensures compliance with U.S. Food and Drug Administration (FDA) and international regulatory requirements. The Senior Attorney will play a key role in interpreting and applying complex regulatory frameworks to support product development, labeling, marketing, and post-market activities in a dynamic, highly matrixed global organization.

Essential Duties and 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.

Key Competencies:

• Regulatory Law Expertise: Demonstrated understanding of the FDCA, FDA medical device regulations, and comparable international frameworks (e.g., IVDR, ISO 13485).
• Analytical Judgment: Ability to identify and assess regulatory risks and provide pragmatic, business-aligned legal solutions.
• Cross-Functional Collaboration: Works effectively across regulatory, quality, and commercial teams in a complex matrixed organization.
• Business Acumen: Understands the interplay between legal advice and business objectives in a scientific, innovation-driven environment.
• Communication: Delivers clear, concise legal guidance to technical and non-legal stakeholders.
• Adaptability: Operates effectively in a fast-paced and evolving global regulatory landscape.

Supervisory Responsibilities:

This is an individual contributor role. The Senior Attorney may provide guidance or informal mentorship to junior attorneys or legal staff but does not have formal direct reports.

Experience/Education:

• Typically requires a minimum of 12 years of related experience with a Bachelor’s degree; or 8 years and a Master’s degree; or a PhD with 5 years of experience; or equivalent experience.
• Juris Doctor (JD) from an accredited law school.
• Experience in medical device, diagnostics, or biotechnology industry, or an equivalent combination of education and experience.
• Licensed to practice law in at least one U.S. jurisdiction.
• Strong knowledge of U.S. FDA regulatory frameworks and related post-market requirements.
• Experience supporting business clients in a regulated environment.

Preferred Credentials:

• 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.

Other Requirements:

• Ability to work across time zones and in a hybrid or global environment.
• Domestic and limited international travel may be required (up to ~10%).
• Willingness to be based in or regularly travel to San Diego preferred.

The estimated base salary range for the Senior Attorney, Legal role based in the United States of America is: $183,700 - $275,500. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. 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.

We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.