Global Partner Quality & Regulatory Leader

Radiometer; Turkey; Remote; TRY 600,000 - 900,000; Full time

Job summary

Danaher Diagnostics seeks a Global Partner Quality & Regulatory Compliance Specialist to oversee pre/post-market regulatory activities and QMS compliance for Türkiye & Azerbaijan. Based in Istanbul and on-site, you will guide regulatory strategy and maintain compliance with EU directives and local regulations.

You will coordinate FSCAs/Field Actions, support ad promo approvals, and drive QMS improvements as Deputy MR. Prior ISO 9001/13485 auditing and strong English are essential.

Qualifications

• University degree in a scientific field.
• 5+ years in Quality/Regulatory Affairs for IVD/medical devices.
• Deep knowledge of IVDD/IVDR regulations.
• Certification by Turkish Medicines and Medical Devices Agency (TİTCK).
• Auditing ISO 9001/13485 with at least 2 years of experience.
• Fluent in English (written & spoken).
• Proficiency in IT tools & AI-driven platforms.

Responsibilities

• Ensure compliance with EU/local directives (IVDR, IVDD, REACH, KKDİK).
• Lead regulatory activities and support promotional materials approvals.
• Maintain Turkish QMS as Deputy MR for ISO 9001.
• Support CAPA, adverse event reporting, and QMS objectives.
• Conduct internal/third-party audits and QMS documentation.

Skills

Quality & Regulatory Affairs

IVD/Medical devices

English fluency

Auditing

IT tools & AI platforms

Education

Scientific degree

TİTCK Certification

ISO 9001/13485 Auditor

Tools

MS Office Suite

AI platform familiarity

Job description

Danaher Diagnostics seeks a Global Partner Quality & Regulatory Compliance Specialist to oversee pre/post-market regulatory activities and QMS compliance for Türkiye & Azerbaijan. Based in Istanbul and on-site, you will guide regulatory strategy and maintain compliance with EU directives and local regulations.

You will coordinate FSCAs/Field Actions, support ad promo approvals, and drive QMS improvements as Deputy MR. Prior ISO 9001/13485 auditing and strong English are essential.