Regulatory Affairs Manager

19 hours ago


Fatih, Istanbul, Turkey Fresenius Medical Care Full time
Quality Assurance Supervisor Job Summary

We are seeking a highly skilled Quality Assurance Supervisor to join our team at Fresenius Medical Care.

The successful candidate will be responsible for supporting the Q&R team in driving Quality & Regulatory compliance while aligning the overall organization to meet business needs & objectives.

  • Supporting the Q&R team in ensuring timely authority reporting for PMS activities.
  • Ensuring an effective Quality Management System is in place, supporting continuity of ISO 13485 and ISO 9001 matrix certificates.
Responsibilities

The Quality Assurance Supervisor will be responsible for:

  • Supporting the Q&R team in driving Quality & Regulatory compliance.
  • Ensuring timely authority reporting for PMS activities.
Qualifications

To be considered for this role, you will need:

  • University degree, scientific discipline preferred.
  • Min. 4-5 years of experience in Quality System Management in medical device and/or pharmaceutical industry (namely, ISO 9001, ISO 13485, CE Marking, MDR, ISO 14001, OHSAS 18001).
  • Auditing experience is a must, preferably having auditor certificates for the above mentioned management systems.


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