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)
Under the leadership of the AVP, Chief Regulatory Officer, the UVMHN Coordinator, Accreditation and Regulatory Affairs assists with the implementation of the organizations regulatory program to assure that an effective and comprehensive regulatory and accreditation readiness program is in place. This program includes but is not limited to compliance with the JC Accreditation Guidelines, CMS Conditions of Participation, Disease Specific Certifications, Program specific accreditations and other state and federally mandated regulatory agency guidelines as appropriate. With the support of the Director, the Regulatory Coordinator is responsible for implementation of key regulatory readiness strategies that promote effective compliance with state and federal standards. This role also functions as the system coordinator for the Document Management System for organization Policies and Procedures
EDUCATION:
State of Vermont Registered Nurse (RN) license required. The University of Vermont Medical Center is moving toward an all Bachelor of Science in Nursing (BSN) workforce. All external candidates hired into, or current employees promoted to, a RN position will be required to obtain their BSN as outlined in the terms of their offer letter. Current internal RNs are strongly encouraged to pursue a BSN to support this initiative.Masters degree preferred.
EXPERIENCE:
Experience in a healthcare environment and experience with interpretation and evaluation of accreditation standards is preferred.-Five years or more of increasing responsibility in systems, quality, or health care administration-Demonstrated management ability-Strong communication/presentation skills-Ability to work with all levels of staff and management-Previous experience with JC/regulatory agency preparation, coordination, education and surveys for hospitals, physician office practices, home health care and free standing ambulatory surgery settings-Previous experience with electronic document management systems (desirable)
About the Company:
The University of Vermont Medical Center
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