Bring more to life.

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

At Radiometer, 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.

In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located.

Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Learn about the Danaher Business System which makes everything possible.

The RA Specialist is responsible for ensuring coordination of regulatory activities for Radiometer products for Taiwan/Hong Kong/Korea to help ensure continued compliance in these markets and growing the Radiometer market share.

This position reports to the Manager, Commercial RAQA, Korea, SEA and Pacific and is part of the Global Commercial Regulatory Affairs department located in Taipei/Taiwan and will be an on-site role.

In this role, you will have the opportunity to:

• Prepare and submit regulatory dossiers for Taiwan and Hong Kong, including document review, implementing country-specific requirements in alignment with Global RA, license maintenance, and communication with partners and authorities. Also manage timelines, budgets, and relevant RA records
• Manage Korea Channel Partner Toolkit (CPTK) and support warranty processes including DA updates and documentation (DDQ, ACC, ACT)
• Ensure regulatory compliance of labelling materials (labels, IFUs, manuals), maintain and update Quality System Documentation (QSD), and support audits and establishment license maintenance in accordance with internal procedures and regulatory requirements
• Support regulatory approvals in other countries (e.g., Southeast Asia, Korea and Pacific), if necessary
• Communicate with local partners and authorities regarding regulatory issues

The essential requirements of the job include:

• A scientific university degree (e.g., biomedical engineering or any relevant)
• Multiple years of professional experience in Regulatory Affairs within the medical device or IVD industry
• Experience in product registration processes for Taiwan and/or Hong Kong, including labelling compliance and regulatory documentation review
• Experience with Quality System Documentation (QSD) management and support for regulatory audits
• Fluency in English, both written and verbal

Travel & Physical/Environment Requirements:

• Occasional travel may be required (<20%), primarily to Hong Kong or Korea
• No heavy lifting or specific physical demands apply to this role

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

• Working in cross-functional or global teams within a regulated industry
• Working proficiency in Korean (to support communication and documentation in Korea RA tasks)

Radiometer, 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.

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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.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.