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Regulatory Affairs Specialist II 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 II monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist II 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 II 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 II typically requires 2 -4 years of related experience.
The Head of Regulatory Affairs and Compliance develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Being a Head of Regulatory Affairs and Compliance anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Establishes monitoring policies and procedures to ensure compliance with existing regulations. In addition, Head of Regulatory Affairs and Compliance investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Head of Regulatory Affairs and Compliance manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head.
The Manager of Regulatory Affairs and Compliance coordinates inspection of the organization and contract facilities, and develops procedures to ensure regulatory compliance. Oversees the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions. Being a Manager of Regulatory Affairs and Compliance typically reports to top management. Requires a bachelor's degree in area of specialty. The Manager of Regulatory Affairs and Compliance manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. Extensive knowledge of department processes. Working as a Manager of Regulatory Affairs and Compliance typically requires 5 years experience in the related area as an individual contributor. 1 to 3 years supervisory experience may be required.