Senior Technical Writer

Job Summary

A company is looking for a Sr. Technical Writer to join their MedTech Surgery business.

Key Responsibilities

• Plan and write Clinical Evaluation Reports (CEPs), Clinical Evaluation Reports (CERs), and Summary of Safety and Clinical Performance Reports (SSCPs)
• Mentor junior writers and conduct technical reviews for document accuracy and compliance
• Lead daily activities to ensure timelines are met and participate in process improvement initiatives

Required Qualifications, Training, and Education

• BA, BS, or BSN is required; advanced degree is preferred
• Minimum of 4 years of related job experience is required
• Experience within the medical device industry and knowledge of global clinical evaluation regulatory requirements
• Proven knowledge and experience in clinical research and quality regulatory compliance
• Familiarity with medical device risk management processes and common statistical methods is preferred