Regulatory Affairs Coordinator

Position Overview

Reporting to the Manager of Regulatory Affairs, coordinates organization-wide as well as program-specific activities related to the regulatory process and the respective governing bodies, including NJ Department of Health, Centers for Medicare and Medicaid Services (CMS), DNV and others. Coordinates activities related to continuous survey readiness, including tracer activity. Acts as a resource for Capital Health staff regarding regulations and requirements.

Assists teams in planning for disease-specific or program-specific certifications and accreditations. Assists with coordinating activities related to on-site and other surveys. Assists teams in the development of action plans and measurement of these actions to measure compliance, and participates in the submission of Novi Surveys to the Department of Health. Works closely with policy owners and users to support the implementation, development, and maintenance of Policy Stat.

Participates in the Policy, Procedure, and Forms Committee to ensure that all policies and forms are reviewed, and published once finalized.

Pay Range: $94,556.80 - $

Scheduled Weekly

Hours:

40

• Education:
  
  Bachelor of Science of Nursing. Master of Science in Nursing, Education, or a related field preferred.
• Experience:
  
  Two years of experience in regulatory affairs. Experience working with project management and/or supporting teams to improve clinical quality and regulatory non-conformances.
• Other Credentials:
  Registered Nurse - NJ, Registered Nurse - PA

• Knowledge of DNV, CMS, and NJ and PA Department of Health standards. Ability to access and search standards to assist clinical teams in meeting goals and maintaining compliance.
• Knowledge of quality and performance improvement tools and techniques. Demonstrates knowledge of data collection, interpretation, and presentation.
• Ability to work on multiple projects and support various tasks simultaneously, exercising discretion and independent judgment to achieve CH goals and objectives.
• Excellent written and verbal communication skills.
• Special Training:
  Proficiency in Word, Excel, and PowerPoint. Proficiency in development and use of tracking tools.

Coordinates organizational and/or departmental activities for regulatory surveys by external agencies such as the NJ Department of Health, the PA Department of Health, and DNV. Works collaboratively with department heads to assure success in the achievement of accreditations, certifications, and recertification’s. Participates in the submission of Novi Surveys to the Department of Health. Ensures preparation and ongoing readiness related to regulatory standards compliance.

Maintains up-to-date knowledge of regulatory requirements and coordinates process changes within Capital Health to ensure compliance. Develops comprehensive and accurate responses to regulatory reports, citations, and requirements for improvement. Works collaboratively with other hospital leaders to ensure timely responses. Coordinates the data collection and submission for the Regulatory Affairs Committee. Assures validated data submission and documentation. Prepares gap analyses and recommends detailed plans for improvement.

Works with various departments to develop tracking tools and other mechanisms to measure regulatory compliance. Coordinates DNV Tracer activity with follow-up reports. Provides consultation to policy owners and users on implementation, revision, and maintenance of policies. Supports the Policy, Procedure, and Forms Committee to ensure policies and forms are disseminated for review and posted to Capital Link when finalized. Performs other duties as assigned.

Frequent physical demands include:
Sitting, Wrist position deviation, Pinching/fine motor. Occasional physical demands include:
Standing, Walking, Climbing (e.g., stairs or ladders), Carry objects, Push/Pull, Twisting, Bending, Reaching forward, Reaching overhead, Squat/kneel/crawl. Continuous physical demands include:
Talk or Hear. Lifting Floor to Waist 20 lbs., Lifting Waist Level and Above 10 lbs. Sensory Requirements include:
A…