Regulatory Affairs Specialist II

Illumina • San Diego, CA

1d

About The Position

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. As a Regulatory Affairs Specialist II, you will have the opportunity to contribute to a variety of regulatory activities supporting new and on-market IVD products as part of a dynamic and collaborative team. 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

• Demonstrated ability to work independently with new, complex technologies, office automation programs and corporate database tools to produce professional work products
• Must be productive, demonstrate the ability to deal with timeline stress, be able to cope with multiple tasks, and be able to prioritize tasks with the supervisor input
• Excellent written and oral communication skills
• Must be able to gather, write, edit and facilitate assembly of memos, and process product and system information for regulatory purposes
• Strong collaborative and detail-oriented work ethic and demonstrated ability to deliver assignments on time
• Typically requires a Bachelor’s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience.
• All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Responsibilities

• Support RA team in coordinating, compiling and preparing document packages for submission to regulatory agencies
• Write and/or edit submission documents using regulatory templates
• Review project documentation for regulatory submission soundness
• Independently contribute to multiple projects/teams within the department.
• Assist with design and process change assessments for regulatory reporting impact and compliance
• Monitor new and revised regulatory requirements; disseminate information as directed by management
• Assist in the review of marketing and promotional literature to ensure they can withstand regulatory body scrutiny
• Actively participate as a member of RA teams and cross-functional project teams
• Write and/or edit process documents using RA templates, or create new templates in support of continuous RA process improvement
• Perform other related duties as assigned

Benefits

• access to genomics sequencing
• family planning
• health/dental/vision
• retirement benefits
• paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level