Collabera
Regulatory Affairs Coordinator
San Francisco, CA, United States
Sponsorship not specifiedDetected 3269 days ago
FDA RegulatoryCommunicationRegulatory Affairs
About the role
- Ensure timely and effective assessments of new regulatory information to determine impact on Illumina products and processes.
- All your information will be kept confidential according to EEO guidelines.
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.
- 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
- Provide administrative support for the activities conducted by the Regulatory Affairs Department.
- Provide support to Regulatory Affairs Department scheduling large event meetings, expense tracking and submission as well as travel planning, purchase order and vendor creation.
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.
- Must be able to gather, write, edit and facilitate assembly of memos, and process product and system information for regulatory purposes
Apply directly at Collabera →Create a free account for alerts like thisView Collabera immigration profile
This listing is sourced directly from Collabera's careers page and normalized into a canonical job model.