Clinical Evaluation Report Writer

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