Global Partner Quality & Regulatory Compliance Specialist

Danaher · Istanbul, Turkey

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RegulatoryFull-timeCompany career page

RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.

Where this listing comes from

This listing was compiled by RoleLantern from the employer's publicly available posting on Workday, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-04 (originally posted 2026-09-09). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.

What they're looking for

University degree in scientific discipline or related field
Minimum 5 years progressive quality and regulatory affairs experience in IVD/medical devices
Deep knowledge of IVDD, IVDR, and related regulations
Turkish TİTCK certification as Medical Device Registration Specialist or equivalent
ISO 9001 and/or ISO 13485 certified internal or lead auditor with 2+ years experience
Fluent English written and spoken communication
Proficiency in MS Office Suite and AI-driven platforms relevant to quality/regulatory

What you'll be doing

Ensure compliance with EU and local directives; manage product registrations and databases
Coordinate field safety corrective actions and field actions with global regulatory teams
Lead implementation and maintenance of Turkish Quality Management System as Deputy Management Representative
Conduct internal and third-party partner audits; maintain QMS documentation
Manage adverse event reporting and CAPA processes; support Quality System Management Reviews

Privacy & handoff

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What RoleLantern checked

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RoleLantern checked active

RoleLantern checkedNeeds clarity

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Date posted26 days ago

Last source checkToday

Salary listedNeeds clarity

Location clearClear

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