Careers at Frestedt Incorporated

Small but mighty.

CRQE Specialist II

General Purpose

To complete Clinical, Regulatory, Quality and Engineering (CRQE) projects for pre-and post-market products while ensuring consistency with regulations, quality standards, commitments and goals.

Essential Functions and Responsibilities

    • Manage individual projects collaboratively with team on behalf of clients to keep projects on time, high quality and within budgets
    • Critically assess and complete project requirements which may include:
      • clinical research studies/clinical evaluation reports (CER)
      • regulatory submissions
      • quality management systems
      • engineering reports
    • Improve quality by suggesting improvements, training and carefully following internal and external SOPs, Work Instructions and Forms/Templates for successful preparation of robust, high quality deliverables
    • Critically assess and follow regulations, standards and guidance documents (e.g. FDA, EU) relevant to client projects across multiple industries and disciplines
    • Develop materials for on-line and in-person training (e.g. PowerPoint presentations)
    • Evaluate and complete literature searches and communicate scientific content in a clear, concise manner
    • Review and assess data content, provide feedback and training to meet client project needs.
    • Other duties as assigned



  • Master’s Degree or PhD in a medical or science-related field or equivalent work experience
  • At least 5 years clinical, regulatory, quality and/or engineering work experience
  • Demonstrate ability to actively manage and complete projects
  • Advanced computer skills with Outlook, Word, Excel, PowerPoint and other software tools
  • Able to productively support and interact with Frestedt Inc. staff and client companies including corporate executives, research sites and research subjects


  • Must be focused, efficient, detail oriented and able to work independently
  • Able to travel to client sites as needed (approximately 10% travel)
  • Demonstrated ability to execute projects on time and on budget
  • Must have excellent critical thinking and problem-solving skills
  • Able to coordinate and conduct training sessions and to secure required training documentation
  • Able to reprioritize immediately as new projects arrive
  • Passion for clinical research, regulatory, quality and engineering affairs activities for pharmaceutical, medical device and food industries

Interested applicants can send their resume and cover letter to with the CRQE Specialist II in the subject line.