Senior Regulatory Compliance Officer

3 weeks ago


Étreux, Hauts-de-France, United States Disability Solutions Full time
About the Role

The Senior QA Specialist, Document Control plays a vital role in our new product team at Disability Solutions, focusing on improving blood-based cancer diagnostic capabilities. This position requires a strong background in quality assurance and regulatory compliance.

Key Responsibilities
  • Lead programs, mentor peers, and develop regulation-adherent processes to improve quality functions, formalized procedures, operations, and systems.
  • Perform document quality checks on all controlled documents in the eDMS, coordinate management of periodic review for required documents within the eDMS.
  • Support and take ownership in the new product development document creation project, ensuring quality and detail in creation/management of documents.
Requirements

Basic Qualifications:

  • Bachelor's degree or related field with 5+ years experience in medical device, diagnostics, clinical laboratory, or biopharmaceutical industry – preferably in QA environment, OR
  • Associate's degree in science or related field with 7+ years experience in medical device, diagnostics, clinical laboratory, or biopharmaceutical industry – preferably in QA environment, OR
  • High School Diploma or General Education Degree with 9+ years of strong experience in medical device, diagnostics, clinical laboratory, or biopharmaceutical industry – preferably in QA environment
Estimated Salary:

$120,000 - $150,000 per annum, depending on location and experience.



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