Careers at Frestedt Incorporated
Small but mighty.
CRQE Specialist II
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 email@example.com with the CRQE Specialist II in the subject line.