Talent.com
Regulatory Specialist
Regulatory SpecialistYale New Haven Health • New Haven, CT, US
[error_messages.no_longer_accepting]
Regulatory Specialist

Regulatory Specialist

Yale New Haven Health • New Haven, CT, US
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Regulatory Specialist

To be part of our organization, every employee should understand and share 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 (e.g. CMS, DPH / DOH, TJC) at the assigned Yale New Haven Health 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 Departments and Committees; e.g. Legal Office, Laboratory Medicine and Quality and Safety 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 delivery network(s) 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.

Responsibilities

  • 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.
  • Acts as an active participant in departmental process improvement to enhance clinical quality and patient safety.
  • Provides key regulatory safety and quality data highlighting business and operational issues requiring management attention and resources.
  • Participates in 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 (e.g. Accreditation and Licensure, CMS Database Forms, ICM completion, measurement of success data, DPH / DOH or CMS corrective action plans, and clinical charter teams).
  • Creates, develops, and delivers educational and training programs and tools relating to compliance issues, safety and quality issues, and continuous regulatory readiness.
  • Provides consultation to clinical and non-clinical departments and serves on multiple committees to continually assess aspects of DPH / DOH readiness and compliance.
  • 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.
  • 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.
  • 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.
  • 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 delivery network(s). Collaborates with department leadership prior to document submission to an external agency.
  • Works collaboratively with the unit and service level medical staff, to set goals / assess delivery network(s) performance, prioritize resources, implement change through facilitation and other activities, and assess individual project success.
  • 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.
  • In collaboration with Director Accreditation and Regulatory Affairs develops and disseminates mock and real survey issues related to regulatory standards and policy compliance.
  • Other projects, assignments, and responsibilities as indicated.

Qualifications

EDUCATION

Current healthcare licensure preferred (e.g. 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 enrollment and completion of a Masters Degree within 5 years of hire 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 (e.g. RN, LCSW, RT / OT)

SPECIAL SKILLS

Proven analytical / problem-solving skills. Outstanding communication, presentation and facilitation skills. Strong computer skills (e.g., 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.

PHYSICAL DEMAND

Travel among assigned delivery network(s) and associated sites is required.

[job_alerts.create_a_job]

Regulatory Specialist • New Haven, CT, US

[internal_linking.related_jobs]
Associate Director, Injectable Drug Product Tech Transfer

Associate Director, Injectable Drug Product Tech Transfer

AstraZeneca GmbH • New Haven, CT, United States
[job_card.full_time]
A leading biopharmaceutical company in New Haven, Connecticut is seeking an Associate Director to lead the development and validation of sterile injectable drug products. Responsibilities include ma...[show_more]
[last_updated.last_updated_1_day] • [promoted]
Associate Director, Injectable Drug Product Technology Transfer

Associate Director, Injectable Drug Product Technology Transfer

AstraZeneca • New Haven, CT, United States
[job_card.full_time]
The Associate Director will lead the development, characterization, technology transfer, and validation of sterile injectable drug products across a range of modalities including biologics, peptide...[show_more]
[last_updated.last_updated_1_day] • [promoted]
Pre-Registration Specialist

Pre-Registration Specialist

Fair Haven Community Health Care • new haven, CT, US
[job_card.full_time]
[filters_job_card.quick_apply]
Fair Haven Community Health Care For over 54 years, FHCHC has been an innovative and vibrant community health center, catering to multiple generations with over 165,000 office visits across 2...[show_more]
[last_updated.last_updated_variable_days]
Senior Specialty Representative - Dermatology - New Haven, CT

Senior Specialty Representative - Dermatology - New Haven, CT

Amgen Inc. (IR) • New Haven, CT, United States
[job_card.full_time]
Senior Specialty Representative - Dermatology - New Haven, CT page is loaded## Senior Specialty Representative - Dermatology - New Haven, CTremote type : Field Workerlocations : US - Connecticut ...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Travel Physical Therapist (PT) - $1,542 to $1,710 per week in St James, NY

Travel Physical Therapist (PT) - $1,542 to $1,710 per week in St James, NY

AlliedTravelNetwork • St James, NY, US
[job_card.full_time]
AlliedTravelNetwork is working with LRS Healthcare to find a qualified Physical Therapist (PT) in St James, New York, 11780!. Ready to start your next travel adventure? LRS Healthcare offers a full ...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Registration Specialist

Registration Specialist

Waterbury Hospital • Waterbury, Connecticut, United States, 06708
[job_card.full_time]
To facilitate a positive patient experiences as well as proper billing procedures, this role is responsible for the accurate completion of all registration related duties including, but not limited...[show_more]
[last_updated.last_updated_30]
Client Relationship Specialist - Lake Grove, NY

Client Relationship Specialist - Lake Grove, NY

Charles Schwab • Lake Grove, New York, United States
[job_card.full_time]
At Schwab, you're empowered to make an impact on your career.Here, innovative thought meets creative problem solving, helping us "challenge the status quo" and transform the finance industry togeth...[show_more]
[last_updated.last_updated_variable_hours] • [promoted] • [new]
Senior Specialty Representative - Dermatology - New Haven, CT

Senior Specialty Representative - Dermatology - New Haven, CT

BioSpace • New Haven, CT, United States
[job_card.full_time]
Senior Specialty Representative – Dermatology – New Haven, CT.Territory covers : Bridgeport, Danbury, Stamford, Norwalk, Harrison NY, and Rye NY. Relocation is not offered for this role.How Might You...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Travel Physical Therapist (PT) - $1,545 to $1,862 per week in Saint James, NY

Travel Physical Therapist (PT) - $1,545 to $1,862 per week in Saint James, NY

Fusion Medical Staffing • Saint James, NY, US
[job_card.full_time]
Travel Physical Therapist (PT).Facility in St James, New York.Fusion Medical Staffing is seeking a skilled Physical Therapist for a 13-week travel assignment in St James, New York.As a member of ou...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Senior Specialty Representative - Dermatology - New Haven, CT

Senior Specialty Representative - Dermatology - New Haven, CT

Amgen • New Haven, CT, United States
[job_card.full_time]
Territory covers : Bridgeport, Danbury, Stamford, Norwalk, Harrison NY and Rye NY.Relocation is not offered for this role. HOW MIGHT YOU DEFY IMAGINATION?.At Amgen, our shared mission—to serve patien...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Credentialing Specialists

Credentialing Specialists

Armada • New Haven, CT, United States
[job_card.full_time]
Type : Full TimeLocation : New Haven, CTOvertime Exempt : YesReports To : ARMADA HQTravel Requirement : YES, nationwide to support onsite credentialing operations as mission needs require.Security Clear...[show_more]
[last_updated.last_updated_variable_hours] • [promoted] • [new]
Laboratory Manager

Laboratory Manager

Lighthouse Lab Services • New Haven, CT, US
[job_card.permanent]
Lighthouse Lab Services has partnered with laboratory in lovely.New Haven, Connecticut, blends Ivy League energy with coastal charm. Home to Yale University, it offers world-class museums, cultural ...[show_more]
[last_updated.last_updated_variable_hours] • [promoted] • [new]
Pharmaceutical Rep

Pharmaceutical Rep

Prism Biotech • Waterbury, CT, US
[job_card.full_time]
[filters_job_card.quick_apply]
If you are looking to work as a Pharmaceutical Sales Representative and promote innovative as well as clinically proven pharmaceutical products then we want to talk to you.We are dedicated to impro...[show_more]
[last_updated.last_updated_variable_days]
Travel Physical Therapist (PT) - $2,086 to $2,313 per week in Port Jefferson, NY

Travel Physical Therapist (PT) - $2,086 to $2,313 per week in Port Jefferson, NY

AlliedTravelNetwork • Port Jefferson, NY, US
[job_card.full_time]
AlliedTravelNetwork is working with LRS Healthcare to find a qualified Physical Therapist (PT) in Port Jefferson, New York, 11777!. Ready to start your next travel adventure? LRS Healthcare offers a...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Associate Director, Injectable Drug Product Technology Transfer

Associate Director, Injectable Drug Product Technology Transfer

Alexion • New Haven, CT, United States
[job_card.full_time]
The Associate Director will lead the development, characterization, technology transfer, and validation of sterile injectable drug products across a range of modalities including biologics, peptide...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Senior Specialty Representative - Dermatology - New Haven, CT

Senior Specialty Representative - Dermatology - New Haven, CT

Amgen SA • New Haven, CT, United States
[job_card.full_time]
Bridgeport, Danbury, Stamford, Norwalk, Harrison NY and Rye NY.Relocation is not offered for this role.HOW MIGHT YOU DEFY IMAGINATION?. At Amgen, our shared mission—to serve patients—drives all that...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Application Specialist

Application Specialist

Milestone Inc. • Shelton, CT, US
[job_card.full_time]
Milestone is an international company that specializes in innovative sample preparation solutions used in laboratories worldwide. With over 25 years of success, Milestone is built on a sustainable o...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Client Director

Client Director

Diaceutics PLC • CT, United States
[job_card.full_time]
Continue with Google Continue with Google.Be among the first 25 applicants.Get AI-powered advice on this job and more exclusive features. Continue with Google Continue with Google.Continue with Goog...[show_more]
[last_updated.last_updated_variable_days] • [promoted]