Compliance Analyst

Role Overview

Compliance Analyst (Contract Remote) supporting medical device labeling and packaging documentation for legacy products. The role is fully remote, with scheduling aligned to U.S. Central Time (8:00 AM–5:00 PM CT).

Responsibilities

• Review labeling-related documentation for ~22 legacy medical device products, including:
  • Packaging labels
  • IFUs (Instructions for Use)
  • Related product files
• Perform gap assessments to identify inconsistencies in product naming across controlled documentation
• Document required labeling and packaging updates using the client’s approved naming convention
• Support execution of approved updates to labeling, packaging documentation, and other controlled files
• Work within document control and change control processes
• Track progress across a high volume of documents to ensure accurate and consistent completion
• Collaborate with client stakeholders to clarify documentation requirements, priorities, and review expectations
• Maintain organized records of reviewed documents, identified gaps, required actions, and completed updates
• Support market launch readiness by helping ensure naming consistency across impacted labeling documentation

Requirements

• Bachelor’s degree in engineering or a related technical field, or equivalent technical certification (≥350 hours)
• Experience with medical device labeling, packaging documentation, quality documentation, regulatory documentation, or document control
• Strong understanding of controlled document environments and regulated medical device workflows
• Experience reviewing/updating IFUs, packaging labels, product files, or related labeling documentation
• Excellent attention to detail and ability to process large volumes of repetitive documentation accurately
• Ability to follow and consistently apply an approved naming convention
• Strong organizational skills for tracking multiple documents/products/updates
• Ability to work remotely while aligning with U.S. Central Time
• Strong written communication skills for clear documentation of findings

Preferred

• Experience supporting EU MDR-related remediation or legacy product remediation
• Prior experience with SmartSolve and/or IQVIA
• Experience with labeling change control, packaging artwork updates, or document management systems
• Background in cardiovascular, implantable, or complex medical devices
• Experience supporting product launch readiness or post-approval remediation