Arun Jeyaram

xUDI Lead.

• Led Baxter xUDI team to ensure timely EUDAMED data submissions for regulatory compliance.
• Collaborated with technical management to address client requirements and strengthen relationships.
• Analyzed customer feedback to enhance user experience in upcoming product releases.

SotA GA Engineer.

• Identified gaps in technical documentation for legacy medical devices per ISO standards for MDR.
• Consulted clients on identified gaps, providing guidance on compliance with updated standards.
• Conducted gap analysis of labeling content through comparative label evaluations.

Management responsibilities.

• Demonstrated expertise in Defect DPA, CAPA, CC activities, ISO audits, and training compliance skill matrix.
• Ensured compliance of operations for successful monthly audits.
• Project management in the PM Smart tool.

• Supported senior engineers in troubleshooting technical issues during production runs.
• Conducted inspections of completed constructions for quality assurance.

• Evaluated student performance through assessments and feedback sessions.
• Utilized diverse teaching styles to address individual learning needs.