Mert Elmas

Orchestrated dispensing, filling, and packing processes for commercial product production, coordinating team activities and overseeing prepared documents to ensure operational efficiency and compliance.

Drove continuous improvement programs, enhancing operational efficiency and compliance across pharmaceutical manufacturing processes.

Managed critical quality management systems, including change control, deviation management, and CAPA, to uphold stringent quality standards and regulatory adherence.

Authored and controlled Standard Operating Procedures (SOPs) and batch records for all production stages, ensuring consistent quality and regulatory compliance (GMP/GLP).

Ensured robust data management and data integrity, maintaining system continuity and compliance with industry standards.

Streamlined product documentation review and approval processes, ensuring timely preparation of FDA and IVDR application files for regulatory submissions.

Developed and reviewed new product development plans for regulatory compliance, collaborating with cross-functional teams to achieve timely regulatory clearance and approval of IVD products.

Prepared performance-related documents for technical files and supported R&D planning, aligning projects with evolving regulations and guidelines.

Designed and implemented clinical research plans for IVD medical devices, specifically for clinical performance evaluation studies.

Assisted in the review and approval of product documentation, contributing to the preparation of FDA and IVDR application files.

Supported the development and review of new product development plans, ensuring alignment with regulatory compliance standards.

Collaborated with cross-functional teams to facilitate timely regulatory clearance and approval processes for IVD products.

Maintained up-to-date knowledge of new and changing regulations and guidelines to ensure project adherence.