Regulatory Compliance Specialist

2 days ago


West Allis, Wisconsin, United States 505 Aurora Health Care, Inc. Full time
Job Title: Regulatory Accreditation Compliance Specialist

This is a full-time, salaried position with 40 hours per week. Usual work hours are Monday - Friday 0800- 1700 with occasional travel on a weekend.

Key Responsibilities:
  • Conduct scheduled internal risk assessments of assigned laboratories to identify quality issues, nonconformities, and opportunities for improvement.
  • Provide on-site guidance and education as needed during internal inspections to assist with improved compliance.
  • Compile deficiency reports and distribute them to lab leadership.
  • Assist with organizing and coordinating on-site inspections, interim self-inspections, and reciprocal (off-site) inspections for assigned laboratories.
  • Participate in regulatory and accreditation inspections.
  • Maintain the CAP website for all facilities, keeping it up to date.
  • Complete reapplication documents for CAP accredited facilities and submit CLIA certificates renewals for CAP accredited sites.
  • Maintain expert competence in regulatory and accreditation standards, including CLIA, CAP, ISO15189, AABB, ASHI, JCAHO, DNV, etc.
  • Communicate relevant changes to appropriate leaders and staff.
  • Maintain close working relationships with leaders of assigned laboratories to ensure performance and quality of services conform to established regulatory and accreditation requirements.
  • Provide education and training on compliance and accreditation matters.
  • Participate in the review, analysis, and development of new tracers and audit plans within the laboratory as needed.
  • Ensure laboratories maintain current federal, state, and local licensure and accreditations, as applicable.
  • Prepare reports and presentations as requested.
Requirements:
  • MT/MLS Certification or equivalent required.
  • Bachelor's Degree from a regionally accredited college/university in chemical, physical, biological sciences, or Medical Technology (Clinical Laboratory Science) required by CLIA.
  • Typically requires 3 years of lab training and experience or both in a non-waived lab (moderate or high complexity).
  • Basic knowledge of CLIA and accreditation (CAP, ASHI, AABB, etc) requirements preferred.
  • At least 2 years of supervisory experience in a diagnostic laboratory setting highly preferred and must at minimum, meet the CLIA personnel requirement of a Technical Consultant.
Knowledge, Skills, and Abilities:
  • Frequent travel within the enterprise system.
  • Ability to work independently and collaboratively.
  • Ability to communicate professionally and effectively, including verbal, nonverbal, and active listening skills.
  • Effective leadership, teaching, coaching, and interpersonal skills.
  • Ability to organize data and generate reports.
  • Organization, planning, and delegation skills.
  • Sound and timely decision-making skills.
  • Highly motivated and results-oriented.
  • Basic to intermediate MS Office skills.
Physical Requirements and Working Conditions:
  • This position requires travel, therefore, will be exposed to weather and road conditions.
  • Operates all equipment necessary to perform the job.
  • Exposed to a normal office environment.
  • Must have a current state driver's license.
  • Must have the ability to travel, sit, stand, and walk throughout laboratories.


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