- 1. As necessary, acts as a key member of projects to improve clinical and non -clinical areas. Partners with internal and external departmental leadership in meeting goals and objectives. Interacts with Managers, Staff, Department Heads, Clinical Service Coordinators, Vice Presidents, and Chiefs of respective departments in relation to projects.
- 2. Acts as an active participant in departmental process improvement to enhance clinical quality and patient safety.
- 3. Provides key regulatory safety and quality data highlighting business and operational issues requiring management attention and resources.
- 4. Participates in hospital task forces, charters and committees to provide operational input and regulatory consultation. Participates in the coordination and completion of multidisciplinary efforts in regard to regulatory preparedness and completion of applications ( Hospital Accreditation and Licensure, CMS Database Forms, ICM completion, measurement of success data, DPH/DOH or CMS corrective action plans, and clinical charter teams).
- 5. Creates, develops, and delivers educational and training programs and tools relating to compliance issues, safety and quality issues, and continuous regulatory readiness.
- 6. Provides consultation to clinical and non-clinical departments and serves on multiple hospital committees to continually assess aspects of Hospital DPH/DOH readiness and compliance.
- 7. In conjunction with other JC/Regulatory Committee members, coordinates tracer rounds (mock surveys) to assess compliance with regulatory requirements and helps prioritize and remediate to improve performance.
- 8. Facilitates and provides coordination of adverse/sentinel event and complaint investigations, root cause analysis, and ensures related improvement plans are met for safety issues recognized by JC, DPH/DOH, and CMS in conjunction with other committee members.
- 9. Under the supervision of the department leadership, supports action plans and measurements of success processes in collaboration with functional and departmental leaders to ensure institution-wide oversight of all regulatory compliance needs related to CMS, DPH/DOH and TJC.
- 10. Under the supervision of department leadership, verifies and validates evidence of action plans and measurements of success data related to regulatory compliance issues for departments or individual action plans in the health system designated hospital delivery networks. Collaborates with department leadership prior to document submission to an external agency.
- 11. Works collaboratively with the unit and service level medical staff, to set goals /assess Hospital delivery network(s) performance, prioritize resources, implement change through facilitation and other activities, and assess individual project success.
- 12. Ensures compliance with regulatory standards (TJC, CMS, DPH/DOH, etc.) for quality and safety reporting under the direction of the Director Accreditation and Regulatory Affairs and others as relevant.
- 13. In collaboration with Director Accreditation and Regulatory Affairs develops and disseminates mock and real survey issues related to regulatory standards and hospital policy compliance.
- 14. Other projects, assignments, and responsibilities as indicated. Qualifications
-
Regulatory Specialist
2 weeks ago
Yale New Haven Health Bridgeport, United StatesOverview: · To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values - integrity, patient-centered, respect, accountability, and compassion - must guide what we do, as individuals and p ...
-
Regulatory Specialist
1 week ago
Lenmar Consulting Holbrook, United States· Title: Regulatory Specialist (Food and Beverage) · Location: Holbrook, NY · Remote/Hybrid/Onsite: Hybrid · Position Type: Contract, possible temp-to-perm · Duration: 6+ months · Rate: $ $29.00/hr · RESPONSIBILITIES: · • Previous experience in an office environment preferred ...
-
Regulatory Specialist
1 day ago
Lenmar Consulting Holbrook, United StatesCompany Description · Food Manufacturing · Job Description · Position will work four days a week remote, but is required to be in Holbrook, NY office one day a week. · Description: · •Previous experience in an office environment preferred · •Monitor and interpret relevant l ...
-
Regulatory Affairs Specialist
3 weeks ago
BioCT Innovation Commons New Haven, United StatesRegulatory Affairs Specialist Jobs · (Found 1 Job) · Nationwide and Remote jobs are not shown · OverviewThe Regulatory Affairs Coordinator will integrate with the RA team and provide general support as needed under the guidance of RA colleagues. This is an exciting opportunity ...
-
Regulatory Compliance Specialist
6 days ago
Global Channel Management Stamford, United StatesExperience And Skills RequiredMinimum of 2-3 years of experience in a Marketing Coordinator role with a strong focus on project management.Preferred experience of 1 year in a Consumer Packaged Goods (CPG) setting.Proficiency in MS Word, Excel, PowerPoint, and Outlook.Familiarity ...
-
Regulatory Affairs Senior Specialist IV
2 weeks ago
CooperSurgical Trumbull, United StatesAbout CooperSurgical CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of d Regulatory Affairs, Specialis ...
-
Regulatory Specialist
2 weeks ago
ACS Holtsville, United States**Title: Regulatory Specialist (Food and Beverage)** · **Location: Holbrook, NY** · **Remote/Hybrid/Onsite: Hybrid** · **Position Type: Contract, possible temp-to-perm** · **Duration: 6+ months** · **Rate: $ $29.00/hr** · **RESPONSIBILITIES**: · **- Previous experience in an offi ...
-
Sr. Regulatory Affairs Specialist
3 weeks ago
Hyperfine Guilford, United StatesCompany ProfileHyperfine (NASDAQ: HYPR) is the groundbreaking MedTech company that created Swoop, the world's first FDA-cleared portable magnetic resonance imaging (MRI) system capable of providing neuroimaging at the point of care. Our mission is to transform patient care by cre ...
-
Principal Regulatory Affairs Specialist
1 week ago
Medtronic North Haven, United StatesLocation field must contain 'city, state' or a zip code to perform a radius search (e.g., Denver, CO or City and state must be separated by a comma followed by a space (e.g., Houston, TX )Medtronic Principal Regulatory Affairs Specialist in North Haven , Connecticut Principal Reg ...
-
Principal Regulatory Affairs Specialist
4 days ago
Werfenlife SA. Bedford, United StatesBedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States · Country · United States · Shift · 1st · About the Position · Overview · Werfen · Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in spec ...
-
Senior Regulatory Affairs Specialist
5 days ago
Medtronic, plc North Haven, United StatesAuthor EU MDR Technical Documentation. Assist in keeping company informed of regulatory requirements in the EU. Participate on cross-functional teams, providing regulatory input in alignment with the EU MDR strategy Review Change Orders and assess re Regulatory, Senior, Surgical, ...
-
Senior Regulatory Affairs Specialist
2 days ago
Werfenlife SA. Bedford, United StatesBedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States · Country · United States · Shift · About the Position · Overview · Werfen · Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related rea ...
-
Regulatory Affairs Specialist
3 weeks ago
BioCT Innovation Commons New Haven, United StatesRegulatory Affairs Specialist Jobs (Found 1 Job) Nationwide and Remote jobs are not shownOverviewThe Regulatory Affairs Coordinator will integrate with the RA team and provide general support as needed under the guidance of RA colleagues. This is an exciting opportunity with pote ...
-
Regulatory Compliance Specialist
2 weeks ago
Global Channel Management Stamford, United StatesExperience And Skills Required · Minimum of 2-3 years of experience in a Marketing Coordinator role with a strong focus on project management. · Preferred experience of 1 year in a Consumer Packaged Goods (CPG) setting. · Proficiency in MS Word, Excel, PowerPoint, and Outlook. · ...
-
Henry Schein Melville, United States Full timeJOB OVERVIEW: · This position is responsible to acquire/maintain/audit company licensing and product registration. Research and analyze applicable legislation and Federal, State and Local regulations to ensure the company's ongoing compliance. Provide guidance to Operations and ...
-
Regulatory Affairs Specialist
2 weeks ago
Partnership HealthPlan of California Fairfield, United StatesOverview: · Under supervision and direction of the Regulatory Affairs Manager, this position assists in supporting the plan-wide HIPAA program and Fraud, Waste, and Abuse (FWA) program and acts as a liaison between the plan and our regulatory agencies. This position coordinates d ...
-
Sr. Regulatory Affairs Specialist
3 weeks ago
Hyperfine Guilford, United StatesCompany Profile · Hyperfine (NASDAQ: HYPR) is the groundbreaking MedTech company that created Swoop, the world's first FDA-cleared portable magnetic resonance imaging (MRI) system capable of providing neuroimaging at the point of care. Our mission is to transform patient care by ...
-
Principal Regulatory Affairs Specialist
1 week ago
Medtronic North Haven, United StatesLocation field must contain 'city, state' or a zip code to perform a radius search (e.g., · Denver, CO · or · City and state must be separated by a comma followed by a space (e.g., · Houston, TX ) · Medtronic · Principal Regulatory Affairs Specialist · in · North Haven , ...
-
Henry Schein Melville, United StatesJOB OVERVIEW: · This position is responsible to acquire/maintain/audit company licensing and product registration. Research and analyze applicable legislation and Federal, State and Local regulations to ensure the company's ongoing compliance. Provide guidance to Operations and ...
-
Quality & Regulatory Specialist-ny
1 week ago
Vitamin World USA Corp Melville, United States**Overview** · The Quality & Regulatory Specialist is responsible for ensuring that all dietary supplement products meet quality standards and comply with state(s) and federal regulatory requirements. This role involves preparing and submitting regulatory documents, coordinating ...
Regulatory Specialist - Bridgeport, United States - Yale New Haven Health
Description
OverviewTo be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values - integrity, patient-centered, respect, accountability, and compassion - must guide what we do, as individuals and professionals, every day.
The position has responsibility and accountability for working to assess, plan, and organize overall regulatory compliance and readiness ( CMS, DPH/DOH, TJC) at the assigned Yale New Haven Health hospital delivery network(s), as well as to participate in the improvement of key processes, policies and procedures as they relate to regulatory compliance. Works as an internal consultant with medical staff, nursing, support services, and other departments to plan, organize, facilitate, implement and measure delivery network efforts to improve process efficiencies, assess regulatory compliance and improve overall patient safety and clinical quality. The Regulatory Specialist provides project management experience necessary to support significant breakthroughs. Responsible for independent action in project oversight, systems design and implementation, quality improvement and a variety of special projects. In conjunction with Hospital Departments and Committees; Legal Office, the Hospital Safety Committee, Laboratory Medicine and Performance Management colleagues, works to assess the impact of quality projects on clinical operations as well as gauge readiness and compliance for internal and external surveys, and adverse event and complaint investigations by CMS, DPH/DOH, TJC, and others as needed. The Regulatory Specialist under the supervision of the Director of Accreditation and Regulatory Affairs has responsibility for site visit preparation, coordination of site visit logistics and response, as well as assist in preparing report-out to management of major regulatory changes and issues of mock or real survey results. The Regulatory Specialist supports activities associated with site visits. The incumbent will support and coordinate clinical safety and quality activities throughout the health system hospital delivery networks and ensure that all safety and quality compliance issues are addressed and resolved in a timely manner. The incumbent will design and provide educational tools and curricula and evaluation of such for standards and issues related to regulatory compliance.
EEO/AA/Disability/Veteran
Responsibilities
EDUCATION
Current healthcare licensure preferred ( RN, LCSW, RT/OT) in the state of Connecticut or Rhode Island, or the equivalent healthcare experience. An advanced degree (MBA, MPH, MSN, or other Masters degree in health related field) or current enrollment is required. Certification (HACP, CJCP, CPHQ are examples) is preferred.
EXPERIENCE
Three (3) to five (5) years of progressive healthcare experience with one (1) to three (3) years of experience in program management, demonstrated teaching experience, and process improvement with clinical operations. Experience and knowledge of TJC standards, CMS Conditions of Participation and experience with accreditation survey process preferred.
LICENSURE
Current healthcare licensure preferred ( RN, LCSW, RT/OT)
SPECIAL SKILLS
Proven analytical/problem-solving skills. Outstanding communication, presentation and facilitation skills. Strong computer skills (, Microsoft PP and Excel) and demonstrated ability to successfully lead process change are needed. Program or project management, effective communication, and planning experience are required. Healthcare background is required.
YNHHS Requisition ID116607
