Senior Design Control Specialist

• Dec 2022 - Present

Design Control Specialist

• Jun 2020 - Dec 2022

- Participating design activities and providing guidance and support to design team as needed in process verifications, validations, risk management, usability, and quality and ensuring ongoing design activities are followed to procedures and related standards, - Supporting risk management activities and change impact evaluations, - Providing support to QA and RA for performing Gap Analysis regarding to changes/updates in regulations and standards,- Perform Design History File (DHF) Verification to ensure validity/availability of required documents of each product based on the design and development process,- Responsible for controlling design activities for R&D projects in both Occlutech GmbH and Occlutech Ltd. Show less

Regulatory Affairs and Quality Assurance Engineer

• May 2018 - Jun 2020

- Carry out reporting, documentation and follow-up procedures in order to ensure the follow-up, implementation and sustainability of Quality Management System (ISO 13485) within the scope of sterile production of biopsy needles, - Oversee documentation efforts to ensure compliance with domestic and international regulations and standards, - Projecting the new products being developed together with the production team, providing the necessary technology / processes and legal requirement and compliance, - Prepare or maintain technical documentation regarding to MDD, MDR, ISO and further applicable regulations as necessary to obtain and sustain product approval, - Monitoring and management of ISO certification and product certification audits. Show less

Medical Device Specialist Assistant

• Oct 2016 - Jul 2017

- Consultancy service for international and local companies about medical device regulations in Turkey, requirements and registration of medical devices in the national knowledge base, process and regulation tracking, - Consultancy for 93/42 and 98/79 Directives - Consultancy service for international and local companies about medical device regulations in Turkey, requirements and registration of medical devices in the national knowledge base, process and regulation tracking, - Consultancy for 93/42 and 98/79 Directives

Intern

• Jun 2015 - Jul 2015

Intern

• Jun 2014 - Jul 2014