Quality Assurance And Regulatory Affairs Specialist
CurrentQuality Assurance• Support in implementation and maintenance of quality management system policies and procedures and ensure compliance with relevant international standards and regulatory requirements.• Manage the documents life-cycle including, but not limited to, issuing templates, reviewing and revising documentation, and routing documents for approval and qualification.• Ensure integrity of all QA files for the purpose of efficient and timely retrieval of generated… Show more Quality Assurance• Support in implementation and maintenance of quality management system policies and procedures and ensure compliance with relevant international standards and regulatory requirements.• Manage the documents life-cycle including, but not limited to, issuing templates, reviewing and revising documentation, and routing documents for approval and qualification.• Ensure integrity of all QA files for the purpose of efficient and timely retrieval of generated documents.• Assist in internal and external audit and inspections.• Manage post-market surveillance activities such as NC, CAPA, complaint, adverse events, FSCA activities and take actions if necessary, to support closure of issues.Regulatory Affairs• Coordinates and collects specific registration information with R&D, Manufacturing, Clinical and other applicable departments, as necessary to support registration requirements.• Review and provide feedback on documentation and supporting evidence to ensure applicable regulatory requirements are met.• Manage product registration, including change notification and renewal, for submission to regulatory authority and monitor the progress, status and timeline.• Maintain product registration record to ensure proper documentation and record filing.• Responsible to ensure that regulatory clearances are obtained in a timely manner in line with expected business plans and responds to potential submission deficiencies. Show less
