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)
Regulatory Affairs position within lifecycle management (LCM). Dependent on the level, responsibilities include contributing to or leading impact assessments and notification plans for product lifecycle changes, assessing applicable health authority regulations, assessing regulatory risks for products (for changes), and capturing and communicating global regulatory requirements for lifecycle management. This role may also help prepare submission files and communicate with Health Authorities to ensure global approval for product lifecycle changes. They may also perform and/or assist with medical device reporting or field actions. This position may require support from senior Regulatory Affairs members and/or managers.
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