Manager, Regulatory Affairs (Remote or Hybrid)

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Position Summary:

The Manager, Regulatory Affairs (RA) will be an instrumental member of the Regulatory Affairs team supporting IVD product development teams, U.S. and international submissions and technical documentation, advertising and promotion review, change management, and regulatory compliance. The incumbent will Interact with various corporate functions and provide regulatory guidance as needed. Write and implement regulatory procedures for continuous improvement. You will be responsible for ensuring timely and effective assessments of new regulatory information to determine impact on Illumina products and processes.

Responsibilities:

• Represents the RA function on assigned cross-functional project teams.
• Interprets and applies regulations by creating regulatory strategies.
• Develops and executes regulatory plans
• Prepares electronic information packages for submission to regulatory agencies.
• Provides recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance.
• Reviews validation, clinical and stability protocols and reports for regulatory submission soundness.
• Assesses manufacturing process and labeling through change control for regulatory reporting impact
• Defines, monitors and receives deliverables for submissions.
• Writes and/or edits submission documents
• Assembles electronic copies for submission.
• Monitors new and revised regulatory requirements; disseminates information as directed by management.
• Interacts with regulatory agencies
• Prepares internal procedures for continuous process improvement.
• Mentors junior members of the department.
• Provides regulatory guidance to external departments and partners.
• Assists with resource planning and budgeting as needed.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Requirements:

• Experience with an in vitro diagnostics device
• Other international requirements - EU
• Demonstrated ability to work independently with new, complex technologies and produce professional work products.
• Strong written and verbal communication skills.
• Team leadership skills preferred.
• Familiarity and ability to work with office automation programs and corporate database tools.
• …