Specialist, Commercial Quality & Regulatory Affairs
Danaher · Taipei
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 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:
Support defined quality and regulatory affairs activities with established procedures, quality system guidelines, and regulatory requirements to include investigations, deviations, complaints, and corrective actions
Support regulatory submissions, filings, renewals, and post-approval changes for commercial products
Support with health authority interactions, audits, and inspections
Assist in preparing quality metrics and reporting for internal management reviews and external audits
Analyze straightforward quality or regulatory issues, evaluate potential solutions using standard procedures, and recommend actions for review
Maintain Regulatory files, track obligations, and ensure information is current in regulatory databases
Work closely with cross functional teams including regulatory affairs, quality, supply chain, and commercial to support quality processes and regulatory responsibilities
The essential requirements of the job include:
Bachelor's degree in Science, Pharmacy, Engineering or related field
3+ years experience or Master's degree in field with 2 years experience
Familiarity with ISO13485 Quality Systems and Regulatory Affairs principles
Demonstrated regulatory or scientific knowledge applicable to medical device or IVD industry in Taiwan or Hong Kong
Strong technical writing, attention to detail, project management, and cross-functional collaboration
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.
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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.