Careers at Frestedt Incorporated

Small but mighty.

CQRE Specialist II

Every day, we choose how we approach our work. Do we relentlessly pursue excellence? Do we honor our commitments to serving and assisting others through our professional gifts? Do we remain intellectually curious and drive the resolution of issues? If you are a Regulatory or Clinical professional and you miss this in your career, then you need to know Frestedt Inc.

Talencio’s client, Frestedt Inc., is an award-winning, full-service strategic partner providing targeted solutions in Clinical, Regulatory, Quality and Engineering within the Medical Device, Pharmaceutical, Biotech and Food Industries. Frestedt Inc. is known for exceptionally high quality services. With a solid and growing client base, the company culture at Frestedt Inc. fosters learning, collaboration, open dialogue and strong work ethics.

 

Frestedt Inc. is growing their team of “Good People Working on Good Projects using Good Processes”, and is hiring a Clinical, Regulatory, Quality and Engineering (CRQE) Specialist to deliver superior services to clients on pre- and post-market products while ensuring consistency with regulations, quality standards, commitments and goals.

 

Essential Functions and Responsibilities:

Responsibilities:

  • Collaboratively manage individual projects 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, and provide feedback and training to meet client project needs
  • Additional responsibilities as needed

Qualifications:

  • Master’s Degree or PhD in a medical or science-related field or equivalent work experience
    4 to 7 years clinical, regulatory, quality and/or engineering work experience
  • Demonstrated ability to actively manage and complete projects
  • Advanced computer skills with Outlook, Word, Excel, PowerPoint and other software tools
  • Evidence of the ability to productively support and interact with staff and client companies including corporate executives, research sites and research subjects

Requirements:

  • Clear reputation for remaining focused, efficient, detail oriented and working independently
  • Demonstrated ability to execute projects on time and on budget
  • Demonstrated excellence in critical thinking and problem-solving
  • A strong passion for continuous learning, with the confidence to speak up about gaps in knowledge, and the intellectual curiosity to pursue that knowledge
  • An appetite for continuous feedback and embracing of an environment fostering open dialogue and informal mentoring
  • Clear ability to coordinate and conduct training sessions and secure required training documentation
  • Demonstrated track record in realigning priorities as new projects arrive
  • Clear passion for clinical research, regulatory, quality and engineering affairs activities
  • Able to travel to client sites as needed (approximately 10% travel)

Qualified candidates, please submit resumes to swyatt@talencio.co