Regulatory Affairs Manager

Location: Burlington, MA
Job ID: 177167-1A
Date Posted: Aug 16, 2022

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Job Description

Welcome To

Welcome to Lahey Hospital & Medical Center, part of Beth Israel Lahey Health. Lahey Hospital & Medical Center is a world-renowned tertiary medical center known for its innovative technology, pioneering medical treatment and leading-edge research. A teaching hospital of Tufts University School of Medicine, the hospital provides quality health care in virtually every specialty and subspecialty, from primary care to cancer diagnosis and treatment to kidney and liver transplantation. It is a national leader in a number of health care areas, including stroke, weight management and lung screenings, among many others. Lahey also helps to advance medicine through research and the education of tomorrow's health care leaders.

About the Job

Under the direction of the Director, Regulatory Affairs, the Regulatory Affairs Manager implements, effectively manages and facilitates activities that support Lahey Hospital & Medical Center’s (LHMC) ability to achieve and sustain compliance with The Joint Commission (TJC), Centers for Medicare and Medicaid (CMS) and Massachusetts state regulations and TJC Accreditation. This includes, but is not limited to, assisting in developing, executing and monitoring a comprehensive regulatory compliance program designed to ensure that 1) LHMC is in compliance with state, CMS and TJC requirements; 2) administrative and clinical leaders are informed of regulatory requirements; 3) compliance is audited and reported on a systematic basis, and 4) opportunities for improvement are identified, communicated and monitored.  The Manager, Regulatory Affairs also supports on site regulatory visits. The position requires knowledge of federal, state and TJC standards and expertise in clinical and operational application to achieve and maintain a continuous state of readiness and compliance with practice expectations.  This includes, but is not limited to, partnering with LHMC leaders to ensure a constant state of readiness; functioning as a liaison between the organization and accreditation or regulatory bodies and acting as resource in continuous improvement activities. The Manager, Regulatory Affairs partners with the Director of Regulatory Affairs to support colleagues in all roles across the organization. This position also requires the ability to develop and maintain a collegial and professional relationship with colleagues, management and the organization’s leadership structure.

Essential Duties and Responsibilities including but not limited to:

1.    Implements LHMC’s continuous readiness program which includes activities that support, at a minimum: coordinating LHMC’s ongoing assessment of compliance; communicating accreditation/regulatory information to all levels of the organization; consulting on and interpreting new and existing standards; providing staff education and training; overseeing continuous readiness auditing and improvement processes; coordinating, facilitating and responding to on-site surveys. 
2.    Serves as a contact for Joint Commission communication; ensuring accreditation documents are current; completing and submitting JC accreditation process requirements as directed; assessing the delivery of safe, high quality care by conducting patient care tracers in all hospital units/departments; facilitating mock surveys by outside vendors and reporting individual and system wide opportunities for improvement to operational managers and clinical and administrative leaders.
3.    Coordinates formal accreditation, regulatory or licensure on-site surveys. Participates in developing and maintains a plan for survey execution, including logistics for notification, activation of the command center, role assignment, providing ongoing survey preparedness training for the leadership team and acting as functioning as a liaison with the survey team throughout the survey.  
4.    Coordinates the development, implementation and monitoring of corrective action plans in response to JC, CMS or state surveys. Manages regulatory team members including assigning and prioritizing work while providing oversight and guidance
5.    Collects, analyzes and reports data in support of continuous readiness activities.
6.    Provides consultative services to all levels of the organization on accreditation/regulatory issues, interpretation of standards and policies, and linkage to clinical and operational processes.
7.    Partners with clinical and administrative leaders and interdisciplinary teams. Identifies need for action based on data analysis identified in key areas of the organization and from external reporting agencies. 
8.    Works with operational leaders to ensure improvement plans are developed, implemented and monitored. 
9.    Participates in the development of educational resources for LHMC colleagues addressing practice standards, policy adherence and regulatory updates. 
10.    Co-leads the readiness steering and leadership teams; integrating elements of ongoing readiness into leadership meetings, orientation, and committee meetings. 
11.    Participates on hospital wide committees, reviewing policies, procedures, and practices for congruence with applicable practice standards
12.    Performs other related duties and participates in special projects as assigned. 
13.    Incorporates Lahey Health Mission Statement and Goals into daily activities.  
14.    Complies with all Lahey Health Policies.
15.    Complies with behavioral expectations of the department and Lahey Health.
16.    Maintains courteous and effective interactions with colleagues and patients.
17.    Demonstrates an understanding of the job description, performance expectations, and competency assessment.
18.    Demonstrates a commitment toward meeting and exceeding the needs of our customers and consistently adheres to Customer Service standards.
19.    Participates in departmental and/or interdepartmental quality improvement activities.
20.    Participates in and successfully completes Mandatory Education.
21.    Performs all other duties as needed or directed to meet the needs of the department.

Minimum Qualifications:

Education: Bachelor of Science degree in Nursing or in a health-related field. A Master’s degree is preferred

Licensure, Certification, Registration:   Not required. 

Skills, Knowledge & Abilities:  Must have (a) excellent oral and written communications skills, (b) working knowledge of the Joint Commission Hospital standards, the CMS Conditions of Participation and Massachusetts State Licensure regulations, and (c) working knowledge of computer spreadsheets and databases; (d) excellent interpersonal skills. 

Experience:   Three-five years of clinical and/or administrative experience with specific experience related to accreditation and regulatory bodies, such as CMS, state licensing agencies, and The Joint Commission. 


40 hours, Day shift

About Us

Beth Israel Lahey Health is dedicated to improving health and wellness and making a difference in the lives of our patients, their families and all members of the communities we serve.  Formed in March 2019, Beth Israel Lahey Health is a patient-centered, integrated care delivery system providing a continuum of services spanning academic, tertiary and community hospitals, dedicated orthopedic and psychiatric hospitals, primary and specialty care, community acute care, ambulatory care, behavioral services and home health.  Beth Israel Lahey Health Performance Network is a unified joint contracting and population health management organization, jointly governed by participating physicians and hospitals.

Equal Opportunity Employer/Minorities/Females/Disabled/Veterans.