Sr. Regulatory Affairs and Quality Assurance

2 days ago

An Giang, Vietnam Radiometer Full time

**Wondering what’s within the Diagnostics Platform and Danaher?**

**Take a closer look.**

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.

Join us in working at the pace of change to improve patient lives

The **Senior Regulatory Affairs (RA) & Quality Assurance (QA) Specialist, Diagnostics Vietnam** will be responsible for regulatory submissions, license management, management of local Quality Management Systems, audit support, and complaint management throughout Southeast Asia. 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 is part of the RA/QA team located in Vietnam and will be remote. This position will report to the Director, RAQA SEA, Danaher Diagnostics.

**Specific duties include but are not limited to**:

- Initiate and maintain product registrations, licensing, change assessments and dossier reviews.
- Interact with regulatory authority/ health agencies to address queries during review.
- Plan and manage Quality System 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 Supplier Management Processes, including qualifications, supplier audits and performance monitoring.

**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.
- Knowledge of ISO 13485, and US FDA 21 CFR Part 820 Quality Systems regulations with experience conducting audits.
- Strong written and communication skills in English and Vietnamese; 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.

Nil

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.

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.

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