Job Title
Manager, Quality Assurance & Regulatory Affairs

Date Posted
9/13/2021

TimeZone
Eastern

As a core member of the quality team, you will be responsible for the build out of the quality management system (QMS) and supporting regulatory affairs functions in the IVD space. Responsibilities include, but are not limited to, drafting FDA Pre-Submission documents, maintenance of the document control system, and review of V&V studies.

Additional requirements:

  • BS/MS/PhD in biochemistry, chemistry, chemical engineering, mechanical engineering, or a related field
  • 5+ years of experience in QA/RA management is required.