Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Description
JOB SUMMARY:
The Regulatory Affairs Specialist is responsible for planning and executing global regulatory strategies necessary to obtain and maintain regulatory approvals for new and modified medical devices in International and US regions. The RAS translates regulatory requirements into project/product requirements, prepares regulatory submissions, and negotiates their approval with regulatory agencies as required. Primary responsibilities include; preparing, International and US regulatory submissions; prepare Technical File, providing documentation for international submissions; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Requirements
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This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.
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