Clinical Evaluation Report Writer

Job Summary

A company is looking for a CER Technical Writer.

Key Responsibilities

• Write Clinical Evaluation Plans and ensure compliant creation of Clinical Evaluation Reports, Plans, and SSCP reports
• Link CER and SSR files to appropriate Quality Systems and Regulatory documents, and manage communication with cross-functional partners
• Assist in developing schedules to meet CER/SSCP timelines and participate in initiatives to define global processes and maintain regulatory compliance

Required Qualifications

• BA, BS, or BSN required; advanced degree preferred
• Minimum of 3 years of related job experience required
• Experience in the medical device industry and knowledge of clinical evaluation report regulatory requirements required
• Preferred knowledge in quality regulatory compliance, complaint handling, and medical device risk management processes
• Regulatory/Notified Body audit experience preferred