Primary Job Functions: Provide administrative support for the activities conducted by the Regulatory Affairs Department. Ensure timely and effective assessments of new regulatory information to determine impact on Illumina products and processes.
Secondary Job Functions: Provide support to Regulatory Affairs Department scheduling large event meetings, expense tracking and submission as well as travel planning, purchase order and vendor creation.
Responsibilities:
• Gather, document and maintain regulatory “intelligence information” for pre-market and post market requirements in US and international countries. Monitor new and revised regulatory requirements and disseminate information to affected parties.
• Support RA team in compiling and preparing hardcopy and electronic information packages for submission to regulatory agencies.
• Define, monitor and receive deliverables for submissions.
• 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
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Requirements:
• A Bachelor’s degree or related experience.
• 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 work ethic and demonstrated ability to deliver assignments on time.
All your information will be kept confidential according to EEO guidelines.