Laboratory Regulatory Affairs Specialist

2 months ago


West Allis, Wisconsin, United States 505 Aurora Health Care, Inc. Full time

Department: WI ACL Laboratories - Regulatory and Compliance

Status: Full time

Benefits Eligible: Yes

Hours Per Week: 40

Schedule Details/Additional Information: This is a full-time salaried position with standard work hours from Monday to Friday and occasional weekend travel.

Key Responsibilities:

  • Conduct comprehensive internal risk evaluations of designated laboratories.
  • Offer expert guidance and education during internal audits.
  • Assist in coordinating both on-site and off-site evaluations.
  • Manage the CAP website for relevant facilities.
  • Maintain a high level of expertise in regulatory and accreditation requirements.
  • Deliver training and educational sessions on compliance topics.
  • Prepare detailed reports and presentations.
  • Support enterprise-wide laboratory quality initiatives.

Minimum Education and Experience Required:

MT/MLS Certification or equivalent is mandatory.

A Bachelor's Degree in chemical, physical, biological sciences, or Medical Technology is required.

A minimum of 3 years of laboratory training and experience in a non-waived laboratory setting.

At least 2 years of supervisory experience in a diagnostic laboratory environment.

Knowledge, Skills, and Abilities Required:

  • Ability to work autonomously as well as collaboratively.
  • Strong leadership, teaching, and coaching capabilities.
  • Excellent organizational and planning skills.
  • Sound decision-making abilities.
  • Highly motivated with a results-oriented mindset.

Physical Requirements and Working Conditions:

Travel is necessary, and exposure to various weather conditions is expected.

Must operate essential equipment for the role.

Work is conducted in a standard office environment.

A current state driver's license is required.

Must be capable of traveling, sitting, standing, and walking throughout laboratory settings.

This job description outlines the general nature of the work expected. It is not an exhaustive list of all duties and responsibilities.



  • West Allis, Wisconsin, United States 505 Aurora Health Care, Inc. Full time

    Job Title: Regulatory Accreditation Compliance SpecialistJoin Aurora Health Care, Inc. as a Regulatory Accreditation Compliance Specialist and play a vital role in ensuring the quality and compliance of our laboratory services.Job Summary:This is a full-time, salaried position responsible for conducting internal risk assessments, providing guidance and...


  • West Allis, Wisconsin, United States 505 Aurora Health Care, Inc. Full time

    Job Title: Regulatory Accreditation Compliance SpecialistJoin Aurora Health Care, Inc. as a Regulatory Accreditation Compliance Specialist and contribute to the success of our organization.About the RoleThis is a full-time, salaried position that requires frequent travel within the enterprise system. As a Regulatory Accreditation Compliance Specialist, you...


  • West Allis, Wisconsin, United States 505 Aurora Health Care, Inc. Full time

    Job SummaryWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at 505 Aurora Health Care, Inc. as an Accreditation Compliance Specialist. This is a full-time, salaried position that requires frequent travel within the enterprise system.Key ResponsibilitiesConduct scheduled internal risk assessments of assigned laboratories to...


  • West Allis, Wisconsin, United States 505 Aurora Health Care, Inc. Full time

    Job Title: Regulatory Accreditation Compliance SpecialistThis 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...


  • West Allis, Wisconsin, United States Advocate Aurora Health Full time

    Job SummaryWe are seeking a highly skilled Medical Technologist to join our team at Advocate Aurora Health. As a Medical Technologist, you will play a critical role in ensuring the accuracy and reliability of laboratory test results, while also providing exceptional patient care and service.Key ResponsibilitiesPerform and evaluate laboratory tests, including...


  • West Allis, Wisconsin, United States Advocate Health Full time

    Job SummaryWe are seeking a highly skilled Medical Technologist to join our team at Advocate Health. As a Medical Technologist, you will play a critical role in ensuring the accuracy and reliability of laboratory test results, while also providing exceptional patient care and support to our clinical teams.Key ResponsibilitiesPerform and evaluate laboratory...

  • Laboratory Director

    2 weeks ago


    West Allis, Wisconsin, United States Advocate Health Full time

    Job SummaryWe are seeking a highly skilled and experienced Laboratory Director to lead our clinical laboratory team at Advocate Health. The successful candidate will be responsible for planning, directing, and overseeing the operation and delivery of services and technical processes within the laboratory.Key ResponsibilitiesDevelop and implement a...

  • Laboratory Director

    4 weeks ago


    West Allis, Wisconsin, United States Advocate Health Full time

    Job SummaryThe Laboratory Director will oversee the operation and delivery of services and technical processes within the laboratory. This individual will be responsible for planning, directing, and implementing process improvement activities, as well as developing and implementing a comprehensive laboratory quality program.Key ResponsibilitiesPlan, direct,...


  • West Allis, Wisconsin, United States Advocate Health Full time

    Key ResponsibilitiesThe Clinical Laboratory Director will oversee the operation and delivery of services and technical processes within the laboratory. This includes planning, directing, and implementing process improvement activities to ensure efficient and effective laboratory results.Leadership and CollaborationDevelop and implement a comprehensive...


  • West Allis, Wisconsin, United States Advocate Aurora Health Full time

    Job SummaryWe are seeking a highly skilled and experienced Clinical Laboratory Director to lead our laboratory operations. The successful candidate will be responsible for planning, directing, and overseeing the delivery of services and technical processes within the laboratory.Key ResponsibilitiesDevelop and implement a comprehensive laboratory quality...


  • West Allis, Wisconsin, United States Advocate Aurora Health Full time

    Job SummaryWe are seeking a highly skilled and experienced Clinical Laboratory Director to join our team at Advocate Aurora Health. As a Clinical Laboratory Director, you will be responsible for planning, directing, and overseeing the operation and delivery of services and technical processes within the laboratory.Key ResponsibilitiesDevelop and implement a...


  • West Allis, Wisconsin, United States Advocate Aurora Health Full time

    Job SummaryThe Senior Laboratory Operations Manager will oversee the day-to-day operations of the department, providing work direction, expertise, and guidance to the staff. This role is responsible for ensuring quality, regulatory, accreditation, compliance, and competency standards are met. The ideal candidate will have leadership experience, including...


  • West Allis, Wisconsin, United States Quad Full time

    Transforming Healthcare with QuadMedAt QuadMed, we're dedicated to revolutionizing healthcare by providing innovative, value-driven services to employers across the nation. As a Clinical Laboratory Technician or Scientist, you'll play a vital role in delivering high-quality diagnostic information to healthcare providers.Key Responsibilities:Perform patient...


  • West Allis, Wisconsin, United States Quad Full time

    Transforming Healthcare with QuadMedAt QuadMed, we're committed to revolutionizing healthcare by providing innovative, value-driven services to employers across the nation. As a Clinical Laboratory Technician or Scientist, you'll play a vital role in delivering high-quality diagnostic information to healthcare providers.Key Responsibilities:Perform patient...


  • West Allis, Wisconsin, United States Quad Full time

    Job Summary: We are seeking a skilled Clinical Laboratory Scientist or Clinical Laboratory Technician to join our team in West Allis, WI. The ideal candidate will have a strong background in medical laboratory technology and excellent communication skills.Key Responsibilities:Perform patient and Quality Control (QC) testingDevelop skills and maintain...


  • West Allis, Wisconsin, United States Quad Full time

    Transforming Healthcare with QuadMedAt QuadMed, we're dedicated to revolutionizing healthcare by providing innovative, value-driven services to employers across the nation. As a Clinical Laboratory Technician or Scientist, you'll play a vital role in delivering high-quality diagnostic information to healthcare providers, empowering patients to achieve their...


  • West Allis, Wisconsin, United States Quad Full time

    Transforming Healthcare with QuadMedAt QuadMed, we're driven by a passion to revolutionize healthcare. Our mission is to empower employees and their families to live healthier, happier lives by providing value-driven health and wellness services in or near the workplace.About the RoleWe're seeking a skilled Clinical Laboratory Scientist or Clinical...


  • West Allis, Wisconsin, United States Novonesis Full time

    Job Title: Application Specialist - Product DevelopmentWe are seeking a skilled and motivated Application Specialist to join our Applications team. The successful candidate will be responsible for conducting experiments, designing and developing Fresh Dairy and Dairy Alternatives prototype application samples, and providing customer application support.Key...


  • West Allis, Wisconsin, United States Novonesis Full time

    Role OverviewWe are seeking a skilled Application Specialist to join our Applications team at Novonesis. The successful candidate will be responsible for conducting experiments, designing and developing Fresh Dairy and Dairy Alternatives prototype application samples, and providing customer application support.This role requires a strong background in food...


  • West Allis, Wisconsin, United States Advocate Health Full time

    Job Title: Toxicology Medical TechnologistJob Summary:We are seeking a highly skilled Toxicology Medical Technologist to join our team at Advocate Health. As a key member of our laboratory team, you will be responsible for performing and evaluating laboratory tests, monitoring workflow, and ensuring the accuracy and reliability of test results.Key...