Job Information
ARUP Laboratories Regulatory Affairs Specialist I in Salt Lake City, Utah
Description
Schedule :Monday - Friday (40 hrs/wk)8:00 AM - 5:00 PM
Department: Corp Compliance Office - 241
Primary Purpose :
The Regulatory Affairs Specialist I monitors and coordinates organization-wide compliance to current requirements of all related regulatory, certifying, licensing, and accrediting agencies. They may operate as a primary point of contact with regulatory agencies and support regulatory activities. Participates in the formulation and execution of new corporate policy, process, and procedure. Provides regulatory training for ARUP employees. Will operate as an integral member of the Corporate Compliance Office team, furthering the collaboration of regulatory compliance programs with emphasis in areas of focus, as assigned. Assists departments with regulatory and compliance goals.
About ARUP :
ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. Based in Salt Lake City, Utah.
ARUP proudly hires top talent to create a work environment of diversity, professional growth and continuous development. Our workforce is committed to the important service we provide to over one million patients each month. We always strive for excellence and have a strong desire to have involvement with the advances in medicine and the role laboratory services plays within each patient’s life. We never forget that there is a patient behind every specimen we receive.
We are looking for individuals who want to contribute to ARUP's culture of accountability, integrity, service, and excellence. Consider joining our dynamic team.
Essential Functions :
Acquires and maintains knowledge of current requirements of federal, state, local governments, specifically in regards to implementation and compliance to those regulations affecting ARUP (e.g. CMS, OIG, DOH, HIPAA, GDPR, FDA, CAP, and CLIA).
Interacts with government agencies as assigned.
Develops and implements proactive programs to support adherence to regulatory requirements and ethical behavior.
Develops and delivers (in coordination with existing training resources) regulatory training and awareness programs.
Designs, develops, and directs compliance initiatives and promotes a culture of compliance and ethics.
Acts as a problem resolution liaison, assisting ARUP employees with questions and issues regarding applicable areas.
Develops/reviews processes to ensure ARUP’s compliance with new and existing corporate regulatory compliance requirements.
Develops and reviews written policies and procedures relevant to areas of responsibility.
Performs audits to support department audit program.
Maintains competency for assigned tasks.
Provides timely response to all ARUP departmental requests and issues within scope of responsibility.
May assist in the following department specialized activities, as assigned:
State, local, and federal licensure requirements for business operation
Public health reporting requirements: including actual reporting, client compliance, regulation review and resource to company and clients.
Privacy program rules: documentation, auditing, investigations, reporting, and training. Assists with Patient Access function.
Risk mitigation and investigation including documentation, auditing, reporting and training
Legal issues: investigation, documentation and correspondence with applicable entities
Other duties as assigned.
Physical and Other Requirements:
Stooping: Bending body downward and forward by bending spine at the waist.
Reaching: Extending hand(s) and arm(s) in any direction.
Mobility: The person in this position needs to occasionally move between work sites and inside the office to access file cabinets, office machinery, etc.
Communicate: Frequently communicate with others.
PPE: Biohazard laboratory environment that requires use of personal protective equipment in accordance with CDC and OSHA regulations and company policies.
ARUP Policies and Procedures: To conduct self in compliance with all ARUP Policies and Procedures.
Sedentary Work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.
Vision: Having close, far, and peripheral visual acuity to perform a variety of tasks such as make general observations of depth and distance.
Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.
Qualifications
Education
Required
- Bachelor's Degree or better
Experience
Required
Bachelor's degree in Business Management, Project Management, Medical Laboratory Science, Biology, Chemistry or related field
One (1) year of work experience in a high complexity clinical laboratory and/or compliance/regulatory experience in a regulated environment
Awareness of applicable state, local, and federal clinical laboratory requirements (e.g., CMS, HIPAA)
Excellent written and oral communication skills
Preferred
Three (3) years of work experience in regulatory, and/or compliance in a regulated environment
Intermediate to advanced experience with all programs in the Microsoft Office Suite
Working knowledge of the clinical laboratory and healthcare delivery system as it relates to government agencies and the enforcement of associated federal and state regulations
Experience interacting with government agencies
Relevant experience at ARUP Laboratories
Demonstrated organizational, critical thinking, problem solving, troubleshooting, and interpersonal skills
Working knowledge of state, local, and federal clinical laboratory requirements, including but not limited to HHS, CMS, OIG, DOJ, HIPAA, GDPR, FDA, DEA, New York, state public health reporting requirements, and CLIA regulations
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)