Job Information
Danaher Corporation Senior Regulatory Affairs and Quality Assurance Specialist, Diagnostics Thailand in Thailand
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
Within Danaher Diagnostics, one of Danaher’s (https://danaher.com/our-businesses) three segments, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact - Danaher's Diagnostics consist of Cepheid, Leica Biosystems, and Radiometer.
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.
The Diagnostics Platform of Danaher Corporation works with conviction that every moment matters and realize that behind every test is a patient, waiting for an answer that could change their life. Our 23,000 team members, across 6 operating companies globally, proudly push the boundaries of what’s possible in safeguarding patient health and improving diagnostic confidence. We develop tools and technologies that set the standard for innovation and impact wherever health care happens—from a family physician’s office to leading trauma hospitals and laboratories. Our teams collaborate in an inclusive environment as we connect our people, processes, and expertise, focused on the world’s biggest health challenges such as cardiac disease, infectious disease, and cancer. At the Diagnostics platform at Danaher, you’ll thrive and quickly see the impact of your contribution.
Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
The Senior Regulatory Affairs (RA) & Quality Assurance (QA) Specialist, Diagnostics Thailand will be responsible for regulatory submissions, license management, local Quality Management System (QMS), audit support, and post-market requirements in Thailand. The Senior Specialist will ensure local and shared Operating Company (OpCo) activities are compliant to the QMS requirements as well as to policies and procedures of the Danaher OpCos.
This position reports to the Director, RAQA SEA, Danaher Diagnostics and is part of the Regulatory Affairs and Quality Assurance team in Southeast Asia and will be an on-site role.
In this role, you will have the opportunity to:
Initiate and maintain product registrations, licensing, change assessments and dossier reviews.
Serve as an in-country representative and subject matter expert for product development and market expansion initiatives, providing regulatory intelligence (review and interpretation of new or revised regulations/guidelines).
Interact with regulatory authority and other health/ government agencies to address queries and other licensing issues.
Plan and manage Quality System processes and related deliverables (key performance indicators) in relation to the shared Danaher OpCos objectives and regulatory compliance requirements. Support Supplier Management Processes, including qualifications, supplier audits and performance monitoring.
Coordinate customer complaints, CAPA, Field Action, AE reporting processes and support post market surveillance activities. Manage the assessment and reporting of post-market events until closure with the regulatory authority.
The essential requirements of the job include:
Bachelor’s degree in Life Sciences or related fields with 5+ years of related work experience.
In-depth knowledge of the knowledge of global regulatory requirements, standards, and guidelines.
Knowledge of ISO 13485, GDPMD (is a must) and US FDA 21 CFR Part 820 Quality Systems (is a plus) regulations with experience conducting audits.
Strong written and communication skills in English and Thai; comfortable working in a dynamic multi-functional matrix organization.
It would be a plus if you also possess previous experience in:
- Technical experience within the in vitro diagnostic or medical device industries.
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.
#LI-TP1 #LI-Remote
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.
Operating Company: Cepheid