Director, Legal (Regulatory and Quality Counsel)

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 product lifecycle. This role involves ensuring compliance with U.S. Food, Drug, and Cosmetic Act, FDA medical device regulations, and EU IVDR. The Director will collaborate with various cross-functional teams, proactively identify regulatory risks, provide strategic legal counsel, and shape Illumina’s engagement with regulators, while also leading and developing a team of legal professionals.

Must Have

• Provide expert legal guidance on U.S. and international medical device regulations.
• Serve as lead legal advisor to Regulatory Affairs and Quality.
• Analyze evolving global regulatory requirements.
• Act as key partner to Sales and Marketing teams.
• Develop and execute legal strategy for major regulatory initiatives.
• Deliver legal risk assessments and mitigation strategies.
• Advise on inspection readiness and regulatory audits.
• Participate in preparing responses to regulatory inquiries.
• Provide guidance on post-market vigilance strategies.
• Oversee engagement with external counsel.
• Collaborate with Commercial Legal on contract terms.
• Advise Business Development team on regulatory issues.
• Provide training and legal updates to functional teams.
• Support SOPs, internal policy updates, and regulatory process improvements.
• Deep knowledge of Food, Drug and Cosmetics Act, EU IVDR.
• Strategic Judgment and Business-Oriented approach.
• Skilled at Matrix Collaboration and Executive Communication.
• Proven Leadership ability.
• Juris Doctor (JD) from an accredited law school.
• Licensed to practice law in at least one U.S. jurisdiction.
• Minimum of 18 years of related experience.
• 10+ years of Management experience.
• Extensive in-house counsel experience in medical device, diagnostics, or biotechnology.
• Demonstrated expertise in FDA regulatory matters.
• Experience advising on EU regulatory frameworks, including IVDR.
• Strong familiarity with legal support for business unit operations in a scientific/regulated environment.

Good to Have

• 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.
• Law firm experience.
• Experience advising on legal and regulatory matters in a matrixed, multinational environment.

Perks & Benefits

• Access to genomics sequencing
• Family planning benefits
• Health, dental, and vision insurance
• Retirement benefits
• Paid time off
• Inclusive environment where employees feel valued and empowered
• 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.

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 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.

Supervisory Responsibilities

This role includes direct supervision of a team of legal professional(s), with responsibility for performance management, coaching and development, workload prioritization, and day‑to‑day oversight. The position is also responsible for hiring, onboarding, and navigating people-related matters in alignment with company policies, values, and evolving workplace expectations.

Experience/Education:

• 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.

Preferred Credentials

• 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.

Other Requirements

• 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.

#LI-ONSITE

#LI-HYBRID

The estimated base salary range for the Director, Legal (Regulatory and Quality Counsel) role based in the United States of America is: $220,500 - $330,700. 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.