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Regulatory Affairs Manager

1 week ago


San Diego, California, United States Illumina, Inc. Full time

Join Illumina, Inc. as a Regulatory Affairs Manager and contribute to the development of innovative genomic sequencing products and services. As a key member of our Regulatory Affairs team, you will ensure compliance with regulatory requirements and support the growth of our business.

Your primary responsibility will be to manage the regulatory aspects of our IVD product development teams, including supporting submissions and technical documentation, advertising and promotion review, change management, and regulatory compliance. You will work closely with various corporate functions to provide regulatory guidance and ensure timely and effective assessments of new regulatory information.

You will also represent the RA function on assigned cross-functional project teams, interpret and apply regulations, develop and execute regulatory plans, and prepare electronic information packages for submission to regulatory agencies. In addition, you will provide recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance, review validation, clinical, and stability protocols and reports for regulatory submission soundness, and assess manufacturing process and labeling through change control for regulatory reporting impact.

To be successful in this role, you should have 7+ years of direct work experience, with 1-3 years of management experience, and a Bachelor's degree or equivalent in a relevant field such as healthcare, diagnostics, or a related field. Additional coursework in regulatory or quality is strongly desired.

We offer a competitive salary, ranging from $115,800 to $173,800, depending on your qualifications and experience. In addition to a salary, you will be eligible for one of our variable cash programs (bonus or commission) and may receive equity as part of your compensation package. We also offer a wide range of benefits, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.