Data Entry Clerk – MDR Remediation (FDA 483 Response)

About the role

The Data Entry Clerk supports a critical remediation initiative responding to an FDA 483 observation. The role ensures accurate Medical Device Reporting (MDR) data across regulatory and quality systems, helping the organization stay audit‑ready and compliant.

Key responsibilities

• Enter, update, and maintain MDR, customer licensing, regulatory submission, and quality log data in internal systems.
• Validate records for completeness, cross‑check information across multiple sources, and flag discrepancies.
• Backlog and remediate historical records to meet regulatory standards.
• Prepare documentation for audits and inspections.
• Provide clerical support such as electronic/physical filing and status tracking.
• Collaborate with Regulatory Affairs, Quality Assurance, and Customer Operations to ensure data integrity.

Required profile

• Strong attention to detail and focus on accuracy.
• Ability to follow structured processes and work with regulated data.
• Good organizational and time‑management skills.
• Comfort with repetitive tasks and consistency.

Required skills

• Microsoft Excel
• Data entry systems
• Document management tools
• ERP systems
• CRM systems