Description:
• Ensure that the in-house quality standards and specifications are maintained and in accordance with regulatory standards
• Responsible for proper documentation in preparation of internal and external audits
• Responsible for handling product complaints
• Responsible for CoA issuing and quality management with contract manufacturers
• Manage and support the execution of new product registration, product registration renewals and change notifications, in timely manner, across Asia
• Assist in compilation and preparation of registration dossiers for submission to regulatory agencies or to commercial partners
• Maintain current knowledge base of existing and emerging regulations, standards or guidance documents
• Maintain data entry to drugTrack and system for tracking changes in registration
• Assist and review product labelling, promotional materials and advertisement for compliance with regulatory requirements
• Liaise with HSA and foreign authorities on matters pertaining to regulatory activities, licenses and permits
• Support Sales & Marketing with tender applications
• Support Regulatory & QA manager other QA matters
• Other ad-hoc duties as assigned
Requirements
1. Minimum 1–2-year experience in QA or Regulatory Affairs with a medical company (Cosmetic, Medical Device, OTC Drug)
2. Knowledge of regulatory guidelines and requirement of countries in Asia Pacific will be a plus
3. GDPMDS/ ISO13485/ GMP knowledge
4. Excellent communication skills and detail oriented
5. Strong organizational and time management skills
6. Good knowledge of Microsoft Office applications
7. Positive attitude and good interpersonal skills
8. Self-motivated, able to work independently as well as in a team