Bring more to life.

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

At SCIEX, one of Danaher’s 15+ operating companies, our work 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.

As part of SCIEX, you will help to influence life changing research and outcomes, while accelerating your potential. For more than 50 years, we have been empowering our customers to solve the most impactful analytical challenges in quantitation and characterization through ground-breaking innovation and outstanding reliability and support. You will be part of a winning team, enabled by DBS, that is passionate about helping life science experts around the world get to answers they can trust.

Learn about the Danaher Business System which makes everything possible.

The Manager, Quality and Regulatory Affairs is responsible for overseeing compliance to quality standards and regulatory requirements for approval and market entry in South Korea and other Asia markets. In this role, you will drive quality and regulatory compliance to align with our global processes and strategies.

This position reports to the Manager, Regulatory Affairs and is part of the Regulatory Affairs team. It is an on-site role located in Seoul, South Korea.  

In this role, you will have the opportunity to:

Ensure compliance of the local team and global QMS to new and updated quality and regulatory standards and regulationsProvide training to the local team as necessary to ensure medical devices are imported and released in alignment with market regulatory requirementsCollaborate with global, cross-functional teams in completing complaint investigations, adverse event reporting, field corrective actions/recalls, and geographic expansion effortsMaintain the import business license with the regional office of the Ministry of Food and Drug Safety (MFDS) and lead device registrations and renewals in South KoreaAct as the Quality Officer for SCIEX in South Korea

The essential requirements of the job include:

Bachelor’s degree in Natural Science, Engineering, Medicine, or equivalent field6 years of experience in quality management/regulatory affairs at a medical device or in vitro diagnostic medical device manufacturing/import companyExperience in maintaining quality management systems to align with local regulations, ISO 13485, and good distribution practicesUnderstanding of Medical Device Act and In Vitro Diagnostic Devices Act regarding medical device importAbility to communicate fluently in Korean and English

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

Interpreting international standards and regulationsRegulatory Affairs certification

SCIEX, a Danaher operating company, offers 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.

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.