Compliance Analyst

• Contract
• Remote 

• Bachelor’s degree in engineering or related technical field (or equivalent technical certification of ≥350 hours).
• Experience in 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 and updating IFUs, packaging labels, product files, or related labeling documentation.
• Excellent attention to detail and ability to work through large volumes of repetitive documentation accurately.
• Ability to follow an approved naming convention and apply it consistently across documentation.
• Strong organizational skills and ability to track multiple documents, products, and updates simultaneously.
• Ability to work remotely while aligning with U.S. Central Time business hours.
• Strong written communication skills and ability to document findings clearly.

• Experience supporting EU MDR-related remediation, technical documentation updates, 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 is a plus.
• Experience supporting product launch readiness or post-approval remediation activities.

• AReview labeling-related documentation for approximately 22 legacy medical device products, including packaging labels, IFUs, and related product files.
• Perform a detailed gap assessment to identify inconsistencies in product naming across controlled documentation.
• Document required labeling and packaging updates based on the approved naming convention provided by the client.
• Support execution of approved updates to labeling, packaging documentation, and related controlled files.
• Work within established document control and change control processes.
• Track progress across a high volume of documents and ensure updates are completed accurately and consistently.
• 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 readiness for market launch by helping ensure naming consistency across impacted labeling documentation.

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