Global Partner Quality & Regulatory Compliance Specialist

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

About the Role

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 which makes everything possible.

Responsibilities

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.

• 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.

Essential 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.
• 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.

Additional Experience (Preferred)

• 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.

Travel Requirements

Travel, Motor Vehicle Record & Physical/Environment Requirements: Ability to travel 10% within region.

Benefits

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.

Company Culture

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.

More Information

For more information, visit www.danaher.com.

About Danaher

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.

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