Quality and Regulatory Affairs Specialist

Would you want to be a part of #teamZEISS?

ZEISS – an internationally leading technology enterprise operating in the fields of optics and optoelectronics. With its solutions, ZEISS constantly advances the world of optics and helps shape technological progress. With over 45.000 employees, ZEISS is one of the global leaders in the optical and optoelectronic industries and has been contributing to technological progress for 178 years now.
As a pioneer in Medical Technology, ZEISS helps doctors all over the world to diagnose and treat diseases more effectively. 

We are seeking a highly motivated and experienced Quality and Regulatory Affairs Specialist to join our team in Türkiye, İstanbul (Ataşehir Office). 

Quality and Regulatory Affairs Specialist acts as quality and regulatory resource for Turkish registration requirements and strategies for assigned in a global scale. Responsibilities include:

• Guide the planning and implementation of the company's quality policy and objectives, promoting quality awareness.
• Review and evaluate the development of the Quality Management System (QMS).
• Coordinate, advise, and train employees on quality management.
• Maintain compliance with Company SOPs and local/global regulations.
• Examine and release quality-relevant documents; inform executives about quality data.
• Coordinate quality improvement measures and ensure QM verification documentation.
• Manage the annual audit program, including auditor selection and internal audits.
• Supervise corrective and preventive actions related to systems and products.
• Record and evaluate customer complaints in collaboration with the Global Quality Team and authorities.
• Attend monthly regulatory and quality calls for follow-up actions.
• Plan and execute national approvals and ensure compliance with Turkish market regulations.
• Serve as the contact for authorities and maintain close communication with the global regulatory/quality team.
• Submit and maintain national medical device registrations, collaborating with authorities and the ZEISS Global Regulatory Team.
• Track CPO and NPS.
• Coordinate the establishment of a Legal Contract Management system.
• Support local occupational health and safety processes in line with global standards.
• Conduct ISO 17025 certification and auditing processes.

Your Profile

• University degree 
• Minimum 5 years' work experience in a similar position in an international company
• Very good command of English
• Very good command of MS Office Applications
• Confident with legal issues and medical device law texts (MDD/ MDR)
• Knowledge of National Product Tracking System
• Familiar with ISO 9001, ISO 17025 and ISO 13485
• Knowledge of In Vitro Diagnostic Medical Devices
• Directive (98/79/EC) / Medical Device Directive (93/42/EEC) / Medical Device Regulation (2017/745)
• No travel restrictions for domestic and international

Join us today. Inspire people tomorrow.
Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.

Your ZEISS Recruiting Team: