Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager 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. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
The Program Manager, Regulatory& Accreditation Affairs is responsible for leading the Nemours Children’s Health, Florida Regulatory and Accreditation program, and managing the respective team(s). The Program Manager's primary goal is to ensure that the Nemours Children’s Health, Florida (NCH-FL) remains compliant with all Federal, State and local regulatory requirements, and adheres to all identified accreditation and certification program standards. The Program Manager is expected to collaborate with the Director, Patient Care Services leaders, and others to craft a vision for a best-in-class program that ensures continuous survey readiness, proactive identification and response to emerging regulatory and enforcement trends, and the sustainability of process and culture around regulatory compliance. The Program Manager will be expected to operationalize that vision in partnership with other key stakeholders including nursing, medical and operational leadership. The Program Manager is expected to serve as a subject matter expert and resource, for the team(s) and committees, for the Q&S Department and for the organization as whole. The Program Manager will demonstrate exceptional critical thinking skills, develop a systematic approach to continuous compliance/readiness, lead and grow teams, and develop individual team members.
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