Senior Analyst, Regulatory Compliance
Illumina
full-time
Posted on:
Location Type: Hybrid
Location: San Diego • California • 🇺🇸 United States
Visit company websiteSalary
💰 $80,900 - $121,300 per year
Job Level
Senior
About the role
- 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.
- Maintain audit and inspection readiness documentation, ensuring accuracy and accessibility.
- Support response preparation, document retrieval, and inspection logistics.
- Prepare and maintain compliance dashboards, reports, and summaries for management review.
Requirements
- Bachelor’s degree in Life Sciences, Chemistry, Regulatory Affairs, or a related discipline.
- Minimum of 5 years of experience in regulatory compliance, quality assurance, or internal audit in the biotechnology, pharmaceutical, or medical device industry.
- Working knowledge of global regulatory standards such as FDA QSR (21 CFR Part 820), ISO 13485, EU MDR, and GxP.
- Experience supporting internal or external audits, inspections, or compliance monitoring activities.
- Strong organizational, communication, and documentation skills.
Benefits
- access to genomics sequencing
- family planning
- health/dental/vision
- retirement benefits
- paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory complianceinternal auditquality assuranceaudit schedulingtest planscompliance metricsCAPAsdocumentationcompliance dashboardsreporting
Soft skills
organizational skillscommunication skillsdocumentation skills
Certifications
Bachelor’s degree in Life SciencesBachelor’s degree in ChemistryBachelor’s degree in Regulatory Affairs