Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes 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 Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Manages meetings, agendas, minutes and needed technology for success. Organizes and completes activities for assigned projects/reports in a timely manner. Coordinates travel arrangements for office staff and others as necessary, to ensure needs are effectively met. Sorts, prioritizes, and distributes incoming mail of both routine and confidential nature. Uses own initiative to compose and type routine correspondence. Provides backup support for Administrative and Executive Assistant.Establishes rapport and cross-coverage with other Senior Management support staff to ensure continuous and appropriate office support needs are met. Completes/reconciles expense reports as needed. Other duties as needed in support of effective management of the Corporate Office and Corporate activities. Acts as receptionist for the Corporate Office by greeting (both in person and on telephone) visitors, patients, volunteers, and employees in a pleasant and professional manner. Makes customers feel at ease by performing office hostess duties. Coordinates the FHPG Board meeting and activities; serves as recording secretary for the Board. Coordinates QualityFirst meetings and other meetings as requested including distribution of meeting notices, agenda preparation, recording minutes, and other necessary administrative support activities. Coordinates supervisors’ schedule and communicates orally and in writing any changes in a timely manner. Communicates information to leadership, staff, physicians, and community members accurately and in a timely manner. Maintains calendar of appointments and activities for CMO, CQO, President FHPG, CSIO. Supports medical affairs leaders as needed. Maintains organized filing system that allows immediate access and retrieval. Maintains library in the Corporate Office. Works in conjunction with the Executive Assistant to update corporate contract database. Acts as payroll preparer for medical affairs and others as assigned.
Associates degree in healthcare or business with minimum of five years’ office support experience required. Bachelor’s degree preferred. Experience within the healthcare environment preferred. Must have strong professional speaking, presentation, writing communication and collaboration skills required. Must be proficient with the Microsoft office suite skills including TEAMS. Organizational skills, critical thinking, and ability to coordinate numerous projects in varying stages ar required. Must have excellent customer service and ability to interact with public. Respects confidentiality requirements of corporate office and abides by HIPAA and patient confidentiality. Ability to take initiative and work independently. Exercises good judgment, at times under stress.
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