Senior Specialist, Commercial Quality and Regulatory Affairs

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.

The Senior Specialist, Commercial Quality and Regulatory Affairs is responsible for interpreting country regulations apply to Danaher Dx products and advising on the impact of regulations, devises strategies for compliance, and liaison with internal and external stakeholders to achieve the licenses, certificates, and other approvals which are in compliance with the MD/IVD regulations and/or other regulations in Taiwan and Hong Kong. This incumbent will evaluate current documentation for compliance with local authority's requirements in regulations and guidelines, determine the need and strategy for regulatory submissions, create feasible resolutions to authority's questions, and secure market clearance and approval for new products and changes to existing products. The QA role involves in building and maintaining commercial operations QMS execution and compliance as required by local authority regulations or Danaher OpCo requirements.

This position will be a part of APAC Commercial QRA Team and report to the QRA Manager responsible of Taiwan/Hong Kong. It will be an on-site role located in Taipei, Taiwan.

In this role, you will have the opportunity to:

• Prepare, review, and submit regulatory documentation for product registrations, site registrations, renewals, and changes to local authorities.

• Monitor local regulatory trends and regulations, assessing their impact on Danaher Dx products and developing mitigation strategies.

• Provides guidance and local regulatory strategy advice to internal stakeholders.​

• Support quality system compliance efforts to ensure commercial operations meet local authority and Global OpCos requirements

• Collaborate with cross-functional teams to drive QRA deliverables to ensure regulatory compliance and continuous improvement.

The essential requirements of the job include:

• Degree in a technical or scientific field is preferred

• Master’s degree with 5+ years of related experience, or Bachelor’s degree with 7+ years of experience in regulatory

• Demonstrated regulatory or scientific knowledge applicable to medical device or IVD industry in Taiwan and Hong Kong

• Experience interpreting complex regulatory requirements and applying them to effective registration strategies or compliance activities

• Proven ability to address ambiguous regulatory or compliance issues and recommend appropriate actions within commercial operations setting

• Strong technical writing, attention to detail, project management, and cross-functional collaboration

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

• Knowledge of Global IVD regulations and CE-IVDR a plus

• Prior experiences of ISO13485 and ISO9001 implementation

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.

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.