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Regulatory Affairs Manager

SCL Health System Denver, CO

Job Description

Regulatory Affairs Manager-18005425 


You bring your body, mind, heart and spirit to your work as a Regulatory Affairs Manager.

You know how to move fast. You know how to stay organized. You know how to have fun.

You're equally comfortable with working with a multi-disciplinary team, possess strong communication skills and have a passion for patient safety.   

You're great at what you do, but you want to be part of something even greater. Because you believe that while individuals can be strong, the right team is invincible. 


Good Samaritan Medical Center is part of SCL Health, a faith-based, nonprofit healthcare organization that focuses on person-centered care. At our 234-bed community hospital, our mission is to bring health and hope to the poor, the vulnerable, our communities and each other. We're especially proud of our people, who helped make us one of America's 100 Best Hospitals according to Healthgrades.

Benefits are one of the ways we encourage health for you and your family. Our generous package includes medical, dental and vision coverage. But health is more than a well-working body: it encompasses body, mind and social well-being. To that end, we've launched a Healthy Living program to address your holistic health. Healthy Living includes financial incentives, digital tools, tobacco cessation, classes, counseling and paid time off. We also offer financial wellness tools and retirement planning.


Together we'll align mission and careers, values and workplace. We'll encourage joy and take pride in our integrity.

We'll laugh at each other's jokes (even the bad ones). We'll hello and high five. We'll celebrate milestones and acknowledge the value of spirituality in healing.

We're proud of what we know, which includes how much there is to learn.

Your day

As a Regulatory Affairs Manager you need to know how to:

·         Provide leadership and direction for the entire organization around regulatory agencies and standards for the hospital and outpatient areas.

·         Manage the coordination of regulatory surveys, including: The Joint Commission, Colorado Department for Public Health and Environment (CDPHE), CMS and/ or other external agency surveys.

·         Collaborate with other department-specific regulatory surveys as requested or required (i.e. Radiation, Centers of Excellence, Disease Specific Certification, etc.).

·         Act as a leader for the Hospital continuous readiness program- including directing an ongoing tracer program, overseeing regulatory process improvement initiatives, planning and coordinating mock surveys, and educating chapter chairs, leadership and associates as needed around new standards and regulations .

·         Serve as a proactive change agent for the organization around regulatory readiness and assists the organization in integration of standards and requirements into practice, along with identification of possible barriers and areas of noncompliance.

·         Align goals with improvement initiatives and organizational need.

·         Collaborate with department facility, and system partners in Risk, Patient Safety, Infection, Environment of Care/ Safety and Quality to ensure alignment of all regulatory and other work.

·         Responsible for the organization's reporting requirements of any safety events that may occur, along with the hospital's annual licensure submissions and other unannounced complaint surveys or letters from The Joint Commission, CDPHE or CMS, OCR, including resolution and follow up of any found deficiencies. This role also acts as the Civil Rights Coordinator for the organization and works in collaboration with the Compliance and Privacy Officer.

·         Involvement in facilitating, coaching, change management, and process improvement and acts as an internal consultant for all levels of the organization which includes strategic planning and coordination of the program, team and project management, and report outs to Directors and/ or Site Leadership with measurable outcomes.


Your experience

We hire people, not resumes. But we also expect excellence, which is why we require:

·         Bachelor's degree required, in a health-related field or 3 years regulatory experience.

·         Current knowledge and proficiency of Regulatory Requirements such as CDPHE, CMS, and Joint Commission.

·         Demonstrated experience and competence in the application of Performance Improvement principles and process change.

·         Strong coaching, teaching and facilitation skills.

·         Excellent oral and written skills.

·         Excellent Office Suite skills, including PowerPoint presentations, Word and Excel

·         Proficient skills in telephone, internet, regulatory applications, and other new technology

·         Patient safety focus

·         Preferred Master's Degree or 5 years of equivalent experience.

·         Previous Management experience preferred 

·         Certification in Regulatory arena (or obtain within 1 year of hire)

Your next move

Now that you know more about being a Regulatory Affairs Manager ­ on our team we hope you'll join us. At SCL Health you'll reaffirm every day how much you love this work, and why you were called to it in the first place. 


: Good Samaritan Medical Center, Lafayette, CO

Primary Location

: CO-Denver/Boulder/Surrounding Areas-Lafayette
Department: GSMC-GSM-Quality Assurance


: Full-time


: Day Shift

Job Posting

: Jul 2, 2018, 2:00:31 PM
FTE: 1.0

 Leadership: Managers and Directors


: Carrie Rose

Job Details

Date Posted July 3, 2018
Date Closes August 2, 2018
Requisition 18005425
Located In Denver, CO
SOC Category 00-0000.00