Clinical Evaluation Specialist

Job Summary

A company is looking for a Staff Clinical Evaluation Specialist (Remote).

Key Responsibilities

• Prepare and update clinical documentation for regulatory body submissions to validate device safety and performance
• Support various business units by communicating clinical data through publications, presentations, and summaries
• Act as the Clinical Evaluation Project Manager to establish and align Clinical Evidence strategies throughout the product development cycle

Required Qualifications

• Minimum of a Bachelor's Degree (B.S. or B.A.) in Life Sciences, Engineering, or a similar concentration
• At least 4 years of experience in an FDA or highly regulated industry, preferably with medical devices
• Minimum of 2 years in a Regulatory Affairs role
• Experience in scientific writing, systematic reviews, and analyzing published literature