Senior Staff Clinical Evaluation Specialist - Remote

Overview

The Senior Staff Clinical Evaluation Specialist will work remotely, collaborating with cross-functional teams to ensure high-quality clinical documents for market availability.

In Short

• Remote position with flexibility to work from home.
• Act as project manager for clinical evaluation strategies.
• Write and revise documents for regulatory submissions.
• Analyze clinical data and synthesize information.
• Communicate with regulators to ensure acceptance of submissions.
• Lead evidence communication with stakeholders.
• Prepare various documents including manuscripts and presentations.
• Support clinical research activities and new product development.
• Identify strategies to enhance team efficiency.
• Must have strong communication and project management skills.

Requirements

• Master's degree in a health/science-related field required.
• 7+ years of industry experience in clinical, quality, or regulatory affairs.
• Ability to analyze and interpret complex documents and regulations.
• Strong planning and organizational skills.
• Demonstrated ability to work independently.
• Strong analytical and problem-solving skills.
• Ability to build strong relationships with stakeholders.
• Experience in writing clinical evaluations for medical devices.
• Doctorate degree preferred.
• Excellent communication and negotiation skills.

Benefits

• Competitive salary and bonus eligible.
• Comprehensive benefits package.
• Opportunity to work with a leading medical technology company.
• Flexible work environment.
• Supportive workplace culture.