Sr. Regulatory Affairs and Quality Assurance

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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.
- 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 _in vitro_ diagnostic or medical device industries.

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