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Regulatory Compliance Specialist

1 month ago

Chicago, Illinois, United States Tempus Full time
Job Summary

Tempus is seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our Document Control team, you will be responsible for ensuring compliance with CAP/CLIA, FDA regulations, ISO, and other regulatory standards.

This is a hybrid role that requires strong analytical and problem-solving skills, as well as excellent communication and collaboration skills. You will work closely with cross-functional partners to ensure timely document reviews and approvals.

Key Responsibilities:

  • Manage and maintain controlled documents within the electronic Document Management System (eDMS) across sites and acquisitions.
  • Support the creation, revision, obsolescence, review, and approval of controlled documents.
  • Collaborate with cross-functional partners to ensure compliance with regulatory requirements.
  • Become well-versed in the electronic Document Management system to facilitate compliant reviews and approvals.
  • Support the implementation of electronic Document Management solutions.
  • Assist in quality metrics related to Document Management and Control.
  • Support continuous improvements in the eDMS and document management and control processes.

Requirements:

  • Bachelor's degree or equivalent related experience.
  • 2+ years of experience in a Document Control or Quality Assurance role within a regulated environment.
  • Experience working in electronic document management systems.
  • Experience working in a medical device, clinical laboratory, or other regulated environment.
  • Intermediate computer skills and software applications.
  • Proven experience in working in a cross-functional team environment.
  • Strong written and oral communication skills, strong attention to detail, and organized.

What We Offer:

  • A competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and collaborative work environment.

How to Apply:

Please submit your resume and cover letter to [insert contact information].