Senior Specialist, RAQA, Diagnostics Vietnam

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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 on-site.

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.

• 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/ 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.

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For more information, visit www.danaher.com.

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