Stryker Singapore Pte Ltd – RAQA (Regulatory Authority Quality Assurance)

Work closely with business partner(designated plants)and agencies to manage relevant country Regulatory Authority registration process.

Monitor all procedure of QA matters and administrative work efficiently. That includes, QMS management, documents filing, database management and reporting.

Maintain close contact with government officials to seek resolutions to issues or formal dispute that may arise.

Process and manage reporting of quality issues to Regulatory Authority as per statutory requirements.

Work collaboratively with manufacturing and internal business partner to provide newly registered product and accurate information, and identify and seek resolution of registration issue for the operational effectiveness. That includes Product complaint, Product Hold, Product Recall and Field Safety Corrective Action.

Assist in planning related projects whenever required. i.e. conduct internal audits and inspections at dealer/outsourced service providers minimum once a year.

Ensure proper documentation and filing of transaction and storage (temperature), pest control records for the purpose of audit.

Ensure proper management of poisons warehouse, check monthly

Assist in internal audits and external ISO 13485 & GDPMD audits, and ensure passing.