Hybrid Senior Analyst, Regulatory Compliance

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About the role

  • Regulatory Compliance Senior Analyst at Illumina supporting compliance auditing and monitoring activities. Collaborating across functions to meet global requirements and uphold ethical standards.

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.
  • 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

Job title

Senior Analyst, Regulatory Compliance

Job type

Experience level

Senior

Salary

$80,900 - $121,300 per year

Degree requirement

Bachelor's Degree

Location requirements

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