What are the responsibilities and job description for the Manager Regulatory Affairs position at Capital Health (US)?
Work Shift
Day (United States of America)
Capital Health is the region's leader in providing progressive, quality patient care with significant investments in our exceptional physicians, nurses and staff, as well as advance technology. Capital Health is a five-time Magnet-Recognized health system for nursing excellence and is comprised of 2 hospitals. Capital Health Medical Group is made up of more than 250 physicians and other providers who offer primary and specialty care, as well as hospital-based services, to patients throughout the region.
Position Overview
Capital Health Job Descriptions
Version
1
Job Title
Manager Regulatory Affairs
Cost Center
000000
Job Code
13409
FLSA Exemption Status
Exempt
Telecommuting Eligible
SUMMARY (Basic Purpose of the Job)
Reporting to the Director, Regulatory Affairs, this position is responsible to manage both organizational as well as programmatic activities related to the regulatory process and the respective governing bodies including but not limited to DNV, ISO-9001, CMS, Department of Health, OSHA, DEP and others. Manages activities related to continuous survey readiness. The manager serves as a resource for Capital Health leaders and staff members regarding regulatory requirements. The manager works closely with teams in planning for program-specific certifications and accreditations. All activities for site surveys are managed. Leads the development of corrective action plans and facilitates the measurement of those actions to assure objective evidence of compliance is achieved.
Education
MINIMUM REQUIREMENTS
Master of Science in Nursing or a related field.
Experience
Two or more years working in the area of regulatory affairs is preferred. Experience working with project management and/or supporting teams to improve acute care hospital structures and processes is needed. Knowledge of performance improvement concepts is an important part of this role. Experience with Leap Frog survey activities and Policy Stat is preferred.
Other Credentials
Registered Nurse - NJ, Registered Nurse - PA
Knowledge And Skills
Knowledge of DNV, ISO-9001, CMS, and NJ Department of Health/PA Department of Health standards. Ability to access and search standards to assist clinical and non-clinical teams in meeting goals and maintaining compliance. Knowledge of quality and performance improvement tools and techniques.
Special Training
Must have proficiency in the use of Word, Excel, and PowerPoint. Must be proficient in the development and use of tracking tools. Familiarity with the submission of New Jersey Department of Health Novi-Surveys as well as Leapfrog Surveys preferred.
Mental, Behavioral And Emotional Abilities
Must have the ability to manage multiple projects and support multiple teams simultaneously. Must exercise discretion and independent judgment to achieve CH goals and objectives. Must have excellent written and oral communication skills.
Usual Work Day
Exempt Hours
Reporting Relationships
Does this position formally supervise employees? Yes
Essential Functions
Frequent physical demands include: Sitting , Pinching/fine motor activities
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: Wrist position deviation , Keyboard use/repetitive motion , Talk or Hear
Lifting Floor to Waist 20 lbs. Lifting Waist Level and Above 10 lbs.
Sensory Requirements include: Accurate Near Vision, Accurate Far Vision, Color Discrimination, Accurate Depth Perception, Accurate Hearing
Anticipated Occupational Exposure Risks Include the following: Dust/Particulate Matter IND123
Offers are contingent upon successful completion of our onboarding process and pre-employment physical. Capital Health will require all applicants (including contractors, travelers and consultants) to have an annual flu vaccine prior to start date, with the exception of individuals with medical and religious exemptions.
"Company will never ask candidates for social security numbers or date of birth during application phase. If you are asked for this information online, you may be a target for identity theft."
Day (United States of America)
Capital Health is the region's leader in providing progressive, quality patient care with significant investments in our exceptional physicians, nurses and staff, as well as advance technology. Capital Health is a five-time Magnet-Recognized health system for nursing excellence and is comprised of 2 hospitals. Capital Health Medical Group is made up of more than 250 physicians and other providers who offer primary and specialty care, as well as hospital-based services, to patients throughout the region.
Position Overview
Capital Health Job Descriptions
Version
1
Job Title
Manager Regulatory Affairs
Cost Center
000000
Job Code
13409
FLSA Exemption Status
Exempt
Telecommuting Eligible
SUMMARY (Basic Purpose of the Job)
Reporting to the Director, Regulatory Affairs, this position is responsible to manage both organizational as well as programmatic activities related to the regulatory process and the respective governing bodies including but not limited to DNV, ISO-9001, CMS, Department of Health, OSHA, DEP and others. Manages activities related to continuous survey readiness. The manager serves as a resource for Capital Health leaders and staff members regarding regulatory requirements. The manager works closely with teams in planning for program-specific certifications and accreditations. All activities for site surveys are managed. Leads the development of corrective action plans and facilitates the measurement of those actions to assure objective evidence of compliance is achieved.
Education
MINIMUM REQUIREMENTS
Master of Science in Nursing or a related field.
Experience
Two or more years working in the area of regulatory affairs is preferred. Experience working with project management and/or supporting teams to improve acute care hospital structures and processes is needed. Knowledge of performance improvement concepts is an important part of this role. Experience with Leap Frog survey activities and Policy Stat is preferred.
Other Credentials
Registered Nurse - NJ, Registered Nurse - PA
Knowledge And Skills
Knowledge of DNV, ISO-9001, CMS, and NJ Department of Health/PA Department of Health standards. Ability to access and search standards to assist clinical and non-clinical teams in meeting goals and maintaining compliance. Knowledge of quality and performance improvement tools and techniques.
Special Training
Must have proficiency in the use of Word, Excel, and PowerPoint. Must be proficient in the development and use of tracking tools. Familiarity with the submission of New Jersey Department of Health Novi-Surveys as well as Leapfrog Surveys preferred.
Mental, Behavioral And Emotional Abilities
Must have the ability to manage multiple projects and support multiple teams simultaneously. Must exercise discretion and independent judgment to achieve CH goals and objectives. Must have excellent written and oral communication skills.
Usual Work Day
Exempt Hours
Reporting Relationships
Does this position formally supervise employees? Yes
Essential Functions
- Manages organizational and/or department activities for regulatory surveys by external agencies such as the NJ/ Pa Department of Health, CMS, DNV, ISO-9001, OSHA, DEP and others.
- Works collaboratively with Department Heads at CH to assure success in the achievement of accreditations, certifications, and re-certifications.
- Ensure preparation and ongoing readiness related to regulatory standards compliance. Works with teams within Capital Health to achieve compliance.
- Maintains up-to-date knowledge of regulatory requirements and manages process changes within CH to ensure compliance. Makes recommendations to enhance regulatory readiness.
- Manages the development of comprehensive and accurate responses to regulatory reports, citations, non-conformities, and requirements for improvement. Works collaboratively with other department managers to plan for and achieve timely responses.
- Manages the data collection and submission for external surveys such as Leapfrog. 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.
- Serves as a resource for teams seeking new certifications and accreditations. Manages the gap analysis process and facilitates the team in working toward their goals.
- Serves as a resource for all departments considering changes in processes. Provides standards to address various issues under consideration.
- Works collaboratively with other departments such as Corporate Compliance, Legal, Risk management, Quality and Patient Safety, and Patient Services to achieve Capital Health goals.
- Plans for and manages on-site surveys (both announced and unannounced). Assures smooth operations during the visits. Collaborates with resources necessary to meet survey objectives.
- Serves as a resource for the Internal Audit Program at Capital Health. Works along-side other department managers and leaders to teach the process and reinforce the structures for the audit process.
- Provides oversight of the Policy Stat system.
Frequent physical demands include: Sitting , Pinching/fine motor activities
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: Wrist position deviation , Keyboard use/repetitive motion , Talk or Hear
Lifting Floor to Waist 20 lbs. Lifting Waist Level and Above 10 lbs.
Sensory Requirements include: Accurate Near Vision, Accurate Far Vision, Color Discrimination, Accurate Depth Perception, Accurate Hearing
Anticipated Occupational Exposure Risks Include the following: Dust/Particulate Matter IND123
Offers are contingent upon successful completion of our onboarding process and pre-employment physical. Capital Health will require all applicants (including contractors, travelers and consultants) to have an annual flu vaccine prior to start date, with the exception of individuals with medical and religious exemptions.
"Company will never ask candidates for social security numbers or date of birth during application phase. If you are asked for this information online, you may be a target for identity theft."
