Staff Clinical Evaluation Specialist - Remote

Overview

The Staff Clinical Evaluation Specialist will lead the planning, writing, and updating of Clinical Evaluation documentation to support the Joint Replacement Division. This remote role involves conducting research, performing systematic reviews, and communicating scientific findings for regulatory submissions.

In Short

• Lead Clinical Evaluation documentation processes (CERs, CEPs, etc.)
• Support regulatory submissions and compliance updates
• Conduct systematic reviews of published literature
• Act as Clinical Evaluation Project Manager
• Analyze clinical and post-market data
• Collaborate with stakeholders on scientific conclusions
• Design literature search strategies
• Identify and address residual risks in Clinical Evidence
• Communicate clinical data through various formats
• Work remotely with a focus on the Eastern and Central USA

Requirements

• Bachelor’s Degree in Life Sciences or Engineering
• 4+ years of experience in a regulated industry
• 2+ years in a Regulatory Affairs role
• Experience in scientific writing and literature analysis
• Strong interest in medical science and clinical research
• Demonstrated project management skills
• Knowledge of FDA/MDR regulations
• Independent problem solver

Benefits

• Competitive salary plus bonus eligibility
• Comprehensive benefits package
• Opportunity to make a significant impact in healthcare
• Work with a leading medical technology company
• Flexible work arrangements
• Equal opportunity employer