Senior Analyst Regulatory Compliance (San Diego/Hybrid) at Illumina

San Diego, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Healthcare, GenomicsIndustries

Requirements

Reside in the San Diego area and be able to commute to corporate offices
Understands core regulatory frameworks (FDA QSR, ISO 13485, EU MDR, GxP) and their relevance to internal audit and compliance functions
Analytical Thinking: Uses data, documentation, and observation to identify potential risks or gaps in compliance
Attention to Detail: Maintains accurate and thorough documentation, ensuring all records meet regulatory expectations
Collaboration: Works effectively across Legal, Quality, Regulatory, and Operational functions in a global environment
Integrity & Ethics: Handles sensitive compliance information with discretion and professionalism
Communication: Prepares clear, concise audit documentation and communicates effectively

Responsibilities

Support the planning and coordination of internal audits across functions and regions
Assist in developing audit schedules, scoping documentation, and test plans
Conduct interviews, gather evidence, and prepare workpapers to support audit conclusions
Evaluate audit findings, document observations, and assist in tracking corrective and preventive actions (CAPAs) through closure
Maintain organized audit records and ensure timely follow-up with stakeholders
Support the implementation and maintenance of Illumina’s Regulatory Compliance Program
Assist in monitoring compliance metrics, reporting results, and identifying trends or recurring issues
Contribute to updates of policies, procedures, and work instructions to ensure alignment with current regulatory standards
Assist in supporting other elements of Illumina’s Compliance Program efforts globally as called upon
Maintain audit and inspection readiness documentation, ensuring accuracy and accessibility
Assist in the coordination of regulatory inspections and external audits (e.g., FDA, ISO, EU MDR)
Support response preparation, document retrieval, and inspection logistics
Prepare and maintain compliance dashboards, reports, and summaries for management review
Identify opportunities to improve audit efficiency and consistency
Support compliance-related training activities and knowledge sharing across teams

Skills

Key technologies and capabilities for this role

Regulatory ComplianceAuditingAudit PlanningCompliance MonitoringCorrective ActionsInspection ReadinessQuality SystemsRegulatory Affairs

Questions & Answers

Common questions about this position

Is this a remote position or does it require office presence?

This is a hybrid role with an expectation of 2-3 in-office days per week and additional on-site presence as needed. The individual must reside in the San Diego area and be able to commute to corporate offices.

What are the key responsibilities for this Senior Analyst role?

The role involves supporting audit execution such as planning, coordination, conducting interviews, and tracking CAPAs; compliance monitoring including metrics tracking and policy updates; and maintaining inspection readiness for regulatory audits like FDA and EU MDR.

What is the salary or compensation for this position?

This information is not specified in the job description.

What is the work environment like at Illumina?

The role operates in a highly matrixed, global environment, partnering with Legal, Compliance, Quality, Regulatory Affairs, and other functions, surrounded by extraordinary people, inspiring leaders, and world-changing projects.

What makes a strong candidate for this regulatory compliance role?

Strong candidates will have experience in compliance auditing, monitoring, and inspection readiness, with the ability to conduct interviews, evaluate findings, track CAPAs, and collaborate across global matrixed teams.

Illumina

Supports genomics startups through funding and resources

About Illumina

Illumina focuses on fostering innovation in the genomics industry by supporting startups through its Illumina Accelerator program. This program helps entrepreneurs create, launch, and grow genomics-focused companies by providing funding and resources. The accelerator operates in two main locations: the San Francisco Bay Area and Cambridge, UK. Illumina Accelerator has successfully invested in 68 genomics startups, which have collectively raised over $1 billion in venture capital. What sets Illumina apart from its competitors is its strong partnership with leading venture capital investors and its dedicated focus on the genomics sector. The goal of Illumina is to build a thriving ecosystem for genomics innovation, enabling new companies to emerge and advance the field.

San Diego, CaliforniaHeadquarters

1998Year Founded

$27.2MTotal Funding

IPOCompany Stage

Venture Capital, BiotechnologyIndustries

5,001-10,000Employees

Risks

Over-reliance on NVIDIA's AI technology may limit flexibility in AI solution adoption.

Standardizing proteomics data across platforms could challenge Illumina's data reliability.

Single-flow-cell NovaSeq X System might cannibalize sales of higher-end models.

Differentiation

Illumina leads in genomic sequencing with advanced AI integration and multiomic data analysis.

The company offers innovative array-based solutions for DNA, RNA, and protein analysis.

Illumina's global expansion includes a new Global Capability Center in Bengaluru.

Upsides

Collaboration with NVIDIA enhances drug discovery and clinical development through AI integration.

Pilot proteomics program with UK Biobank aims to generate crucial reference datasets.

Single-cell sequencing kits make high-throughput sequencing accessible to smaller labs.

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