MURVET SARI KANBUR

• Support global regulatory submissions and product registrations through preparation and review of Design Verification, Stability, Risk Management, and Design Control documentation.
• Support regulatory impact assessments associated with design, packaging, labeling, and component changes.
• Collaborate with Regulatory Affairs, Packaging, Labeling, Manufacturing, Supply Chain, and Quality teams to implement design changes and maintain regulatory compliance.
• Develop design control documents, including DCPs, user needs, system requirements, and traceability matrices for project implementation.
• Participate in design reviews and create records that capture decisions, gaps, and follow-up actions for the R&D team.
• Coordinate implementation follow-up with Packaging and Labeling teams to close documentation gaps and support project updates.

Major Regulatory and Registration Accomplishments
Repsol
• Supported FDA submission activities and collaborated with project teams to address FDA queries, resulting in successful approval.
• Coordinated with EMEA teams on inventory forecasting and regional supply planning prior to approval.
Puma
• Led labeling creation activities, Certificate of Analysis (CoA) preparation, and Design Verification support.
• Contributed to successful regulatory approvals from COFEPRIS (Mexico) and ANVISA (Brazil).
Orion Curitiba
• Supported plant teams during Design Verification activities required for INMETRO approval.
PPICC 3CG Component Change Registration
• Supported successful registration approval of Canaan SKU 301029 with approximately $8M business impact.
EUPPWR
• Supported regulatory submissions involving packaging material changes for CE-marked products.
BDPI 10mL LL Syringe China Submissions
• Provided Stability and Design Verification support for China submissions related to Chronic PPA catheter products including PleurX and PeritX.
• Supported product portfolio with approximately $7M business impact.
Regional Registrations and Registarations Renewals
• Supported product registration activities for Korea, LATAM and China.

• Updated [number] Class I–III device drawings weekly to align with EU-MDR 2017/745 and CE marking requirements.
• Assessed patient-contact components for regulatory impact, including CoCr and stainless steel, and coordinated testing conditions with Regulatory Affairs.
• Participated in design reviews and documented outcomes in formal design review records.
• Tracked drawing revisions and compliance changes across cross-functional teams to support timely EU-MDR execution.

• Developed and qualified new adhesive peel force test methods and equipment for the Libertas 5 ml product line.
• Wrote and reviewed design verification reports, test protocols, and manufacturing specifications across multiple BD delivery products.
• Partnered with plants on CAPA, root cause analysis, and investigation work to close product and process gaps.

• Designed store shelves, wall parts, and gondolas for CVS Pharmacy cosmetic displays in SolidWorks.
• Applied Design for Manufacturing and Design for Assembly practices with SolidWorks and PDM Vault.
• Compiled part groups in SolidWorks and Microsoft Excel to support cost analysis and planning.
• Developed 2D and 3D documentation in SolidWorks and Illustrator for carrier trays and social media walls.
• Prepared instruction manuals with exploded views and updated drawings to support CVS store assembly steps.

• Designed indoor vegetable growing unit subsystems, including water circulation, germination, and automatic fertilizer dispensing.
• Sourced efficient, cost-effective components for the water circulation system to support reliable operation.
• Developed vegetable tray concepts in SolidWorks, balancing water flow, drainage, and root clogging concerns.
• Benchmarked competitor products and market trays, then applied findings to improve Farmshelf tray design.
• Partnered with rapid prototyping and injection molding vendors in China to refine plastic injection design and mold flow analysis.

• Applied design control processes to guide product development for regulated home appliance programs.
• Performed design verification and validation across products using rapid prototyping to support manufacturing decisions.
• Contributed to new product development for home appliances such as PARFUME application in dryer, EGGY (egg boiler and peeler), NEXT GENERATION SILENT HAIR DRYER, aligning designs with regulatory requirements.
• Understanding the business impact, working with the suppliers and creating strategic thinking and project implementation plans.

• Designed flow forming machine subsystems for MKEK and ROKETSAN using Inventor and metal process techniques.
• Completed the hydraulic deep drawing press design for kitchen tubes as a bachelor degree thesis, applying structured engineering methods.
• Created hole H-type hydraulic press designs, including hydraulic systems, with Inventor and AutoCAD.