Mert Elmas
Quality Systems Engineer | Regulatory & Quality Assurance Specialist
İstanbul, TR.About
Highly analytical and results-driven Quality Systems Engineer with a strong background in Nanoscience and Molecular Biology, specializing in pharmaceutical and medical device industries. Proven expertise in establishing and optimizing quality management systems, ensuring regulatory compliance (GMP, GLP, ISO 13485, IVDR, FDA), and driving continuous improvement initiatives. Adept at managing complex documentation, leading cross-functional teams, and facilitating timely product clearances to enhance operational efficiency and market readiness.
Work
İstanbul, İstanbul, Türkiye
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Summary
As a Quality Systems Engineer, Mert Elmas leads compliance initiatives and optimizes production processes for commercial pharmaceutical products.
Highlights
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.
İstanbul, İstanbul, Türkiye
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Summary
As a Project Management Specialist, Mert Elmas facilitated regulatory submissions and R&D initiatives for medical devices, ensuring compliance and timely market access.
Highlights
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.
İstanbul, İstanbul, Türkiye
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Summary
As a Project Management Assistant Specialist, Mert Elmas supported regulatory documentation and R&D project planning for medical devices.
Highlights
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.
Languages
English
French
Skills
Quality Management Systems
IVDR, GMP, GLP, ISO 13485, Quality Assurance, Regulatory Compliance, Change Control, Deviation Management, CAPA, SOP Development, Data Integrity.
Project Management
Project Planning, Cross-functional Collaboration, Documentation Management, R&D Support, Time Management, Organization.
Regulatory Affairs
FDA Applications, IVDR Applications, Regulatory Clearance, Medical Device Regulations, Clinical Performance Evaluation Studies.
Research & Development
New Product Development, Clinical Research Plans, Technical File Preparation, Scientific Research.
Communication
Stakeholder Communication, Team Coordination, Report Writing.
References
Onur Kaya
Bioeksen R&D Technologies / RA&QA Assistant Executive, Phone: +90-533-966-7998, Email: onur.kaya@bioeksen.com.tr