Senior Regulatory Affairs - Recall & Post-Market (Remote)

Illumina; Northern (KY); Hybrid; USD 90,000 - 135,000; Full time

Benefits offered by this job

Genomics sequencing access

Health, dental, vision benefits

Retirement benefits

Paid time off

Job summary

Illumina is seeking a Senior Regulatory Affairs Specialist to support on‑market IVD products in the U.S. and international markets. The role focuses on post-market compliance, adverse event reporting, field actions, recalls, and regulatory assessments.

You will guide cross-functional teams, develop regulatory strategies, and ensure timely submissions while contributing to continuous process improvements within a global framework.

Qualifications

• Typically requires 5+ years of regulatory affairs experience with a Bachelor's degree; or 3 years with a Master’s; or a PhD with no experience.

Responsibilities

• Rep RA function on cross-functional project teams.
• Interprets regulations to create regulatory strategies for domestic and international markets.
• Develops and executes regulatory plans for new products and maintenance of existing approvals.
• Prepares information packages for regulatory submissions (paper/electronic).
• Reviews labeling, validation, clinical/stability protocols for compliance.

Skills

Regulatory affairs

FDA regulations

Cross-functional teamwork

Regulatory submissions

Education

Bachelor’s degree in life sciences

Master’s degree or PhD (preferred)

Tools

MS Office

Regulatory databases

Job description

Illumina is seeking a Senior Regulatory Affairs Specialist to support on‑market IVD products in the U.S. and international markets. The role focuses on post-market compliance, adverse event reporting, field actions, recalls, and regulatory assessments.

You will guide cross-functional teams, develop regulatory strategies, and ensure timely submissions while contributing to continuous process improvements within a global framework.