Clinical Evaluation Specialist
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
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
