Sr. Regulatory Affairs and Quality Assurance Specialist, Diagnostics SEA

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The family of Diagnostics companies at Danaher work 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.

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The Senior Regulatory Affairs (RA) & Quality Assurance (QA) Specialist, Diagnostics SEA will be responsible for managing the local Quality Management Systems, executing regulatory project submissions and license management. The responsibility includes ensuring local and shared Operating Companies (OpCos) activities are complying to the QMS requirements as well as to policies and procedures of the Danaher OpCos. This position is part of the RA/QA team located in Singapore and will be on-site.

This position will report to the Director, RAQA SEA, Danaher Diagnostics.

Specific duties include but are not limited to:

• Initiate HSA registrations, special assess licensing, and change submissions with close collaboration with cross-functional teams to support the achievement of business objectives. As and when required, to provide in-country assessment of dossier and technical file 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).
• Maintain local Quality Management System for GDPMDS/SS620 certification. Plan and manage Quality Systems processes and related deliverables (Key Performance Indicators) in relation to the shared Danaher OpCos objectives and regulatory compliance requirements.
• Coordinate customer complaints, CAPA, Field Action, AE reporting processes and support post market surveillance activities.
• Support the Supplier Management Process, including qualifications, supplier audits and performance monitoring
• Provide support to regulatory compliance and quality related projects.

The essential requirements of the job include:

• Bachelor's degree in Life Sciences or related fields with 3+ years of related work experience.
• Experience leading regulatory submissions and interactions with regulatory authorities in different countries with an in-depth knowledge of global regulatory requirements, standards, and guidelines.
• ISO 13485 internal/lead auditor certification or equivalent.
• Strong knowledge of HSA requirements of GDPMDS/SS620 and medical device registrations.
• Strong written and communication skills in English, and comfortable working in a dynamic multi-functional organization.

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

• Technical experience within the diagnostic or medical device industries.

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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.

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