Quality and Regulatory Affairs Specialist

ZEISS Group

Application Deadline: 01 Jan 2026

ZEISS Group
Summary

Vacancy: 1

Salary: $13000 - $16000

Age: 22 to 38

Experience: 1-2 years

Location: Turkey

Published on: 23 Dec 2024

Job Context


Job Responsibilities

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


Experience Requirements
  • 1 - 2 years
Educational Requirements
  • Bachelor/Honors
Skills
  • 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 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
Age
  • 22 - 38 Age
Additional Requirements

Compensation & Other Benefits
  • - Mobile Bill , Tour , Holidays , Performance Bonus
  • - Salary Review: Half Yearly
Work place
  • Work At Office
Employment Status
  • Full Time
Gender
  • Male
Job Location
  • Turkey
Company Information

ZEISS Group

Carl-Zeiss-Str. 22 Oberkochen, 73447, DE

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