Global Partner Quality & Regulatory Compliance Specialist

Danaher Corporation; Ataşehir; On-site; TRY 4,412,000 - 6,373,000; Full time

Job summary

Danaher Corporation’s Diagnostics group seeks a Global Partner Quality & Regulatory Compliance Specialist based in Istanbul, Türkiye, on-site. You will oversee pre- and post-market regulatory activities and maintain the Quality Management System to ensure compliance across IVDR/IVDD, local regulations, and partner policies.

You will lead audits, coordinate field actions, support CAPA processes, and mentor the commercial team on regulatory requirements.

Qualifications

• University Degree in a Scientific discipline or a closely related field.
• Minimum of 5 years of progressive experience in Quality and Regulatory Affairs for IVD and/or medical devices. Deep knowledge of IVDD, IVDR and related regulations.
• Certification issued by the Turkish Medicines and Medical Devices Agency (TİTCK) as a Medical Device Registration Specialist or Responsible Manager or Sales and Promotion Representative or Clinical Support Specialist.
• Certified Internal or Lead Auditor for ISO 9001 and/or ISO 13485 standards, with at least 2 years of auditing experience.
• Fluent in English (both written and spoken).
• Proficiency in IT tools, MS Office Suite, and familiarity with AI-driven platforms or applications relevant to Quality and Regulatory Affairs

Responsibilities

• Ensure full compliance with relevant EU and local directives (IVDR,REACH, KKDİK etc.), managing timely product registrations and maintaining the product registration database.
• Coordinate Field Safety Corrective Actions (FSCAs) and Field Actions, provide regulatory guidance on legislation and environmental regulations to the commercial team, coordinating with RA Global and Business Units, and support the approval of promotional materials
• Lead the implementation, maintenance, and continuous improvement of the Turkish Quality Management System (QMS), serving as the Deputy Management Representative for ISO 9001 compliance.
• Support and contribute to QMS objectives and projects, including the management and reporting of adverse events and robust CAPA handling processes.
• Conduct internal and third-party partner audits, maintain QMS documentation, and support Quality System Management Reviews.

Skills

English fluency

Education

University degree in scientific discipline

Tools

MS Office

AI platforms

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

Within Danaher the work our diagnostic businesses do saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

We’re accelerating the development of cutting-edge diagnostics to solve some of the world’s most pressing health challenges. Across our diagnostics operating companies we are driving innovation through partnerships with top academic institutions and leading players in biopharma and translational research. We’re bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together, we’re expanding access to precision diagnostics for millions of people worldwide - and we’re using our unmatched global scale and proven playbook to make it happen, from hospital labs to mobile clinics. By helping providers, patients, and families get faster, more precise diagnostic results, we’re improving treatment options and saving lives.

Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

The Global Partner Quality & Regulatory Compliance Specialist is responsible for pre and post-market regulatory activities and all activities associated with the Quality Management System to comply with Beckman Coulter, Leica, Radiometer, and Cepheid policies and procedures, as well as the required International Standards and Regulatory requirements linked to the Türkiye & Azerbaijan commercial organization

This position reports to the Global Partner Quality & Regulatory Compliance Manager and is part of the DHR Dx Commercial QRA located in Istanbul, Türkiye and will be an on-site role.

In this role, you will have the opportunity to:

• Ensure full compliance with relevant EU and local directives (IVDR,REACH, KKDİK etc.), managing timely product registrations and maintaining the product registration database.

• Coordinate Field Safety Corrective Actions (FSCAs) and Field Actions, provide regulatory guidance on legislation and environmental regulations to the commercial team, coordinating with RA Global and Business Units, and support the approval of promotional materials

• Lead the implementation, maintenance, and continuous improvement of the Turkish Quality Management System (QMS), serving as the Deputy Management Representative for ISO 9001 compliance.

• Support and contribute to QMS objectives and projects, including the management and reporting of adverse events and robust CAPA handling processes.

• Conduct internal and third-party partner audits, maintain QMS documentation, and support Quality System Management Reviews.

The essential requirements of the job include:

• University Degree in a Scientific discipline or a closely related field.

• Minimum of 5 years of progressive experience in Quality and Regulatory Affairs for IVD and/or medical devices. Deep knowledge of IVDD, IVDR and related regulations

• Has certification issued by the Turkish Medicines and Medical Devices Agency (TİTCK) as a Medical Device Registration Specialist or Responsible Manager or Sales and Promotion Representative or Clinical Support Specialist.

• Certified Internal or Lead Auditor for ISO 9001 and/or ISO 13485 standards, with at least 2 years of auditing experience.

• Fluent in English (both written and spoken).

• Proficiency in IT tools, MS Office Suite, and familiarity with AI-driven platforms or applications relevant to Quality and Regulatory Affairs

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel 10% within region

It would be a plus if you also possess previous experience in:

• Experience working across multiple geographies and within matrixed organizations.

• Hands‑on experience leading or supporting Continuous Improvement initiatives using Lean, Six Sigma, or Danaher Business System (DBS) tools.

• A general awareness of AI trends in the industry

Within Danaher Diagnostics, we offer a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com .

Operating Company: Cepheid