Careers at Frestedt Incorporated

Small but mighty.

CQRE 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 o 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

Qualifications:

  • 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

Requirements:

  • 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 info@frestedt.com with the CRQE Specialist II in the subject line.