DescriptionSchedule :Monday - Friday (40 hrs/wk)8:00 AM - 5:00 PMDepartment: Quality Systems & Support - 252Primary Purpose :The Quality and Regulatory Affairs Specialist I monitors and coordinates organization-wide compliance to current requirements of all quality related regulatory, certifying, licensing, and accrediting agencies. The Quality and Regulatory Affairs Specialist I assists with the coordination and maintenance of the regulatory submissions for new certificates, licenses, and updates to laboratory director roles with accrediting agencies. They may operate as a primary point of contact with regulatory agencies including but not limited to: CAP, CLIA, CMS, FDA, NY, ISO, DNV, and California. The Quality and Regulatory Affairs Specialist I frequently supports regulatory activities and supports ARUP’s quality management System (QMS). This may include maintaining accuracy of the laboratory activity menu, coordinating or oversight of proficiency testing functions, coordinating responses to compliance notices, and facilitating or participating in regulatory agency audits to include oversight and guidance of deficiency responses, where necessary.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 and other accrediting and licensure bodies, specifically in regards to ARUP’s compliance to those regulations affecting global quality and compliance processes (e.g. ISO, NY, CLIA, CAP, FDA). Provides regulatory resource to ARUP departments, as required.Develops/reviews processes to ensure ARUP’s compliance with new and existing corporate regulatory compliance requirements. Such processes may include development/review of written policies and procedures, internal and external audits, and document control.Prepares audit tools in conjunction with Quality Coordinators. Performs audits, mock inspections, and surveys as assigned. Prepares written and verbal reviews of all audits.Uses working knowledge of applicable regulations and standards to contribute to the development and approval of tests, management of clinical operations, and compliance with ARUP’s QMS.Manages the regulatory aspects of ARUP activities in order to meet requirements, timelines and deliverables and to maintain compliance with applicable standards, regulations and policies. This may include coordinating, organizing, administering, and documenting proficiency testing for offsite locations. Represents ARUP to regulatory agencies. This may include serving as a primary point of contact for questions and hosting meetings with the regulatory agencies.Authors and reviews applicable policies and procedures to ensure compliance with regulatory agencies requirements.Serves as a consultant to the technical sections and the organization regarding current regulations and guidelines.Researches regulatory requirements to support ARUP’s operational goals.Organizes and manages regulatory applications to accrediting agencies.Leads, coordinates, serves as point of contact, and liaison with the technical sections for regulatory compliance notifications and responses.Leads audits or inspections from sponsors and regulatory authorities and facilitates the preparation of audit responses.Performs gap assessments of ARUP’s regulatory submissions for new requirements and manages any remediation activities.Supports and provides regulatory recommendations to technical and quality management, Quality Officer, CMO, and COO, other leadership as needed.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 and effectively 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.Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.QualificationsEducationRequired
Bachelor's Degree or better in Business Management
Licenses & CertificationsPreferred
Applicable ASCP or AAB
Applicable ASQ
Lean Six Sigma
ExperienceRequired
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 quality/regulatory experience in a regulated environment
Excellent written and oral communication skills
Preferred
Three (3) years of work experience in quality, regulatory, and/or compliance in a regulated environment
Experience at ARUP in a technical section
Working knowledge of regulatory requirements applicable to clinical laboratories
Demonstrated knowledge of ISO, CLIA, CAP, NY, FDA and DNV requirements
MT, MLS or categorical ASCP certification
Quality specialty certification, preferably from ASQ (e.g., six sigma black belt, certified quality auditor, etc.,)
Intermediate to advanced experience with Microsoft Word, Excel, and PowerPoint
Demonstrated organizational, critical thinking, problem solving, troubleshooting, and interpersonal skills
Experience in Good Manufacturing Practices, Good Laboratory Practice and/or Good Clinical Laboratory Practice
Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe 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)