We are seeking a regulatory affairs specialist in Orange County! Preparing regulatory submission for submission, including US 510K, European Union Technical File, and Health Canada submissions. Provide business level support for International Registrations. Review labeling for Regulatory compliance. -Maintains awareness of global regulatory legislation and its impact on business and product development programs. Provide expertise and guidance to project teams in interpreting US and foreign governmental regulations, agency guidelines, and internal/corporate policies to ensure compliance is maintained and results are achieved. Work in close collaboration and partner with other departments and functions, including manufacturing, Quality and Regulatory, Supply Chain, Research & Development, and Clinical to optimize overall operational efficiency and effectiveness.
2-4 years experience needed minimum
Certification in regulatory affairs is a plus!
Must have FDA experience
Documentation
Effective Time Management
Regulatory audits and inspections
Research & Development
Verbal communication
written communication
Adaptability
Detail Oriented and Organized
Multi-tasking
According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Irvine, CA, USA is between $74,000 and $98,000 per year. The salary range can vary based on experience and qualifications.
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