Illumina
Director, Legal (Regulatory and Quality Counsel)
Illumina, San Diego, California, United States, 92189
Director, Legal (Regulatory and Quality Counsel)
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About Illumina 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 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 research‑use‑only product lifecycle. The role plays a critical function 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 & 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.
Act 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, 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 professionals, 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.
Compensation & Benefits Estimated base salary range: $220,500 – $330,700. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location, internal equity, and market data. Employees are eligible for variable cash programs (bonus or commission) and may receive equity as part of the compensation package.
Benefits include access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.
Equal Employment Opportunity Illumina is a committed equal‑opportunity employer, fostering an inclusive environment where employees feel valued and empowered. We are proud to have a zero‑net gap in pay, regardless of gender, ethnicity, or race, and maintain various Employee Resource Groups (ERG) that enhance professional development and cultural awareness.
The company 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 related decisions are 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. For accommodation requests, contact accommodations@illumina.com.
To learn more, visit the U.S. Department of Labor EEO poster: 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.
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About Illumina 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 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 research‑use‑only product lifecycle. The role plays a critical function 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 & 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.
Act 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, 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 professionals, 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.
Compensation & Benefits Estimated base salary range: $220,500 – $330,700. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location, internal equity, and market data. Employees are eligible for variable cash programs (bonus or commission) and may receive equity as part of the compensation package.
Benefits include access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.
Equal Employment Opportunity Illumina is a committed equal‑opportunity employer, fostering an inclusive environment where employees feel valued and empowered. We are proud to have a zero‑net gap in pay, regardless of gender, ethnicity, or race, and maintain various Employee Resource Groups (ERG) that enhance professional development and cultural awareness.
The company 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 related decisions are 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. For accommodation requests, contact accommodations@illumina.com.
To learn more, visit the U.S. Department of Labor EEO poster: 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.
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