Job Summary

A staffing agency needs applicants for an opening for a Remote Clinical Evaluation Writer in Fremont.

Must be able to:

• Provide advanced scientific writing expertise for multiple projects in all therapeutic areas
• Serve as the scientific writing content expert for the department
• Evaluate data for similar competitor devices

Position Requirements Include:

• Willingness to travel to the Fremont office up to 1 time a month
• Master's degree with clinical research exposure required
• 1-2 years of regulatory writing experience, with some exposure to medical devices
• 5+ years of CER writing experience in a medical device company, CRO, or agency
• Knowledge of 510(k), MedDEV 2.7.1 Rev 4, MDR, and other relevant medical device regulations
• Experience across document types and therapeutic areas/diseases