Global Partner Quality & Regulatory Compliance Specialist

About the role

Join Danaher’s diagnostics portfolio to ensure that products sold in Turkey and Azerbaijan meet all regulatory and quality standards. You will work on both pre‑market and post‑market activities, supporting the commercial organization while driving continuous improvement of the Quality Management System.

Key responsibilities

• Ensure compliance with EU and local directives (IVDR, REACH, KKDİK) and manage timely product registrations.
• Maintain the product registration database and coordinate Field Safety Corrective Actions (FSCAs) and other field actions.
• Provide regulatory guidance to the commercial team and support approval of promotional materials.
• Lead implementation, maintenance, and improvement of the Turkish QMS, acting as Deputy Management Representative for ISO 9001.
• Support QMS projects, manage adverse‑event reporting, and oversee CAPA processes.
• Conduct internal and third‑party partner audits, keep QMS documentation up‑to‑date, and assist in Quality System Management Reviews.

Required profile

• University degree in a scientific discipline or a closely related field.
• Demonstrated experience in regulatory affairs and quality management within life‑science or diagnostic environments.
• Strong knowledge of EU and Turkish regulatory frameworks (IVDR, REACH, KKDİK).
• Familiarity with ISO 9001 and QMS implementation.

Required skills

• IVDR
• REACH
• KKDİK
• ISO 9001
• Quality Management System (QMS)
• Regulatory Affairs
• Product Registration
• CAPA handling
• Adverse Event Reporting
• Audit Management