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 recordsManage 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 requirementsSupport regulatory approvals in other countries (e.g., Southeast Asia, Korea and Pacific), if necessaryCommunicate 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 industryExperience in product registration processes for Taiwan and/or Hong Kong, including labelling compliance and regulatory documentation reviewExperience with Quality System Documentation (QSD) management and support for regulatory auditsFluency in English, both written and verbal

Travel & Physical/Environment Requirements:

Occasional travel may be required (