A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

To ensure the Department of Pathology operating units (clinical laboratories and other administrative functions) are compliant with all regulatory requirements, including but not limited to CLIA and the College of American Pathologists (CAP) standards. Collaborates with laboratory leadership, management, and staff to ensure all appropriate local, state, and federal regulations are followed. Provides consultative services to internal staff and external clients and performs appropriate activities to document compliance with regulatory requirements. 

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally.  Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems.  In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

• Serves as point person for planning and facilitating biennial and interim year CAP inspections 
• Ensures laboratory documentation is up to date and submitted to CAP and/or CLIA as staff, equipment, and test menus change 
• Provides input to the CLIA Laboratory Director and laboratory leadership re: implementation of CLIA regulations in the laboratories. 
• Serves as the Pathology Department's representative on the Michigan Medicine Accreditation and Regulatory Readiness Committee (ARRC) and participates in initiatives as required.  
• Ensures compliance with regulations from other agencies as appropriate to the Department of Pathology (e.g., New York, California, FDA, etc.) 
• Suggests and helps implement training with regards to educating laboratory staff on compliance.  
• Develop risk management strategies 
• Coordinate with Pathology and Michigan Medicine partners for projects related to improving compliance readiness.  
• Interfaces with Infection Prevention, Accreditation, Safety Management, Acute Care, Ambulatory Care, Health System Administration, Facilities, and Value Analysis to ensure adherence to regulatory requirements, standards and best practices. 
• Oversee compliance with upcoming FDA Laboratory test development regulations. 
• Work closely with department administrators, compliance and regulatory managers, clinical division directors, and laboratory leadership to establish ongoing compliance for current and future LDTs. 
• Track regulatory changes and FDA interpretive positions affecting LDTs.
• Lead and support 510k submissions 
• Collaborate with team members to ensure complaint registration, device listing, labeling, and event reporting, as applicable.
• Assist with responding to requests from the FDA or other regulatory agencies.
• Organize and maintain files related to compliance efforts and internal and external inspections.
• Maintain an adverse event reporting system, which includes, but is not limited to, determining necessary modifications to the current system as applicable; developing a new system from internal resources; and /or soliciting proposals from outside vendors.
• Serve as the regulatory expert on the internal department committee for evaluation of proposals for the development of new LDTs
• Contribute to the development of internal processes for managing new proposals, LDTs actively in development or submission phases, and other monitoring needs.
• Educate Michigan Medicine leadership and departmental staff on the evolving regulatory landscape regarding LDTs.

CHARACTERISTIC DUTIES AND RESPONSIBILITIES 

• CAP  8 sites (UH/Mott, NCRC, East Ann Arbor Surgery Center, Kellogg Eye Center, Northville, West Ann Arbor, Brighton Center for Specialty Care, MEND at Domino?s Farm) 
• Accreditation renewal application and maintenance of account
• Proficiency testing compliance 
• Plan and perform both the internal and external CAP inspection 
• Lab General Checklist ? Compliance, but joint responsibility with labs and Operations Directors 
• Maintain documents within the document control system pertaining to compliance. 
• CLIA (State of Michigan) ~50 sites 
• Oversight of CLIA certificates  update test menu, lab director, etc. 
• Institutional Compliance  
• TJC chapters  Waived Testing, standards within Provision of Care, CMS 42 CFR 482 
• Regulatory Readiness survey oversight of Waived Testing  
• ARRC monthly meetings 
• Other Regulatory Agencies 

Awareness and assist additional regulatory agency inspections such as: 

• AABB 
• ASHI 
• FACT 
• FDA 
• NAME  

Out of State Regulatory Agencies 

• California
• New York 

SUPERVISION RECEIVED 

The Compliance Manager works under the supervision of the Clinical Pathology Operations Director and the direction of the CLIA Laboratory Director 

SUPERVISION EXERCISED 

Quality Assurance Coordinator Safety and Preparedness Position 

WORKING CONDTIONS/PHYSICAL REQUIREMENTS 

• May have exposure to noise from laboratory equipment. 
• Requires frequent (standing/walking/sitting) for potentially long periods of time.

Advanced degree in health care administration, regulatory affairs, or related.
Previous experience in laboratory compliance. 
FDA medical device or related experience.
Demonstrated ability to independently organize and prioritize work.
Membership and participation in professional organizations as they relate to this position.
Knowledge in implementation of a laboratory information system. 
Reasonable knowledge of university and departmental policies, procedures and regulations. 
At least 5 years working experience in all phases of Pathology.

This full time, 40 hour position will be M-F, and is exempt, as such it is expected to require additional hours both during the week, on weekends and off shifts to complete projects, inspections, or work assignments that may include deadlines. It will also include on-call.

This position will primarily be located in the North Campus Research Complex, however it may require travel to University of Michigan Hospitals and all sites throughout Southeast Michigan.

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings.  Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Job openings are posted for a minimum of seven calendar days.  The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

The University of Michigan is an equal opportunity/affirmative action employer.