David Silva

Prepare, review, and submit pharmaceutical licensing applications and renewals with supporting regulatory documentation. Serve as a primary point of contact for regulatory authorities and manage communications, deficiency resolution, and deadline tracking to support compliant approvals.

• Prepare, review, and submit pharmaceutical licensing applications, renewals, and supporting documentation in accordance with state and federal regulatory requirements. Ensure all submissions are accurate, complete, and compliant with applicable regulations to facilitate timely approvals and maintain business continuity
• Serve as a primary point of contact with regulatory authorities, includin

• Supported regulatory compliance activities for laboratory and analytical instruments across the CELA region (Colombia, Costa Rica, Ecuador, Nicaragua, and Panama) by performing installation, qualification, maintenance, and calibration in accordance with manufacturer specifications, ISO 17025, and quality management system (QMS) requirements.
• Maintained accurate service, calibration, and te

• Supported regulatory compliance activities for 3Shape dental medical devices by ensuring products were used and serviced in accordance with manufacturer specifications, quality management system (QMS) procedures, and applicable medical device regulations.
• Maintained accurate technical service documentation, installation records, and device performance reports, supporting product traceabili

• Developed and implemented operational strategies for electrophysiology (EP) and 3D mapping medical devices, improving workflow efficiency and reducing equipment wait times by 40% through optimized clinical logistics and procedural planning.
• Served as a technical and clinical liaison between medical teams and internal stakeholders, providing specialized product support, training, and guidance b

• Participation in the maintenance of basic and life support biomedical equipment, along with the execution of calibration procedures
for biomedical equipment, ensuring the precision and accuracy of measurements.
• In-house maintenance and technical support in healthcare institutions, collaborating with experienced professionals in
troubleshooting and improving maintenance processes.
• Development