We are a global leader in manufacturing of medical devices and deliver solutions to improve lives through today’s technology and future innovation. The company is in the critical care medical business of improving lives through todays’ technology and future innovation. We are now seeking for highly motivated individuals to join our dynamic team to continually develop and support our ever-expanding international business.
JOB ROLE:
This position is responsible to assist the Regulatory Affairs (RA) Department for local regulatory matters, notarization, legalization, research work, provide administrative support and occasionally assist on Quality Assurance (QA) functions.
DUTIES AND RESPONSIBITIES:
1.Singapore – Local Regulatory Support:
- Assist the RA team for local regulatory matters
- HSA submission
- Free Sales Certificates
- Responding to distributors or other parties’ request for free sales certificates
- Renewal of product licenses
- Application of Export Certificates
- Assist in any other local regulatory matters, such as change notifications or communicating with HSA to clarify any issues
- SAP
- To understand how the company system in legal control of registered product before selling to market
- Assist RA team for SAP required tasks (Raise PR and etc.)
- Respond to other departments requests (e.g. Customer Service when outward bound shipment is blocked)
2. Product Registration (APAC):
- Assist RA team’s regulatory projects
- Providing required information and documents
- Compile dossier for submission
- To understand the various regulatory requirements
- Liaising with distributors to understand their requests
- Compile documents, samples etc. required for submission, which involves interacting with the various departments and distributors
- Draft required documents such as letter of authorization or declaration
3. Legalization of Documents:
- Documents for overseas usage will often require legalization
- To familiarize with the legalization procedures and the varying requirements from the various Embassies
- Arranging to send documents for legalization
- Manage payment for legalization
4. Administrative Support:
- Taking of minutes and organization of documents
- Handling shipment documents sent locally and overseas
- Ad-hoc project on QMS documentation management and data analysis for audit preparation
- Occasionally provide support for other relevant tasks for RA & QA functions
- Assist on any ad-hoc tasks as required by the department manager
Related Job Searches:
- Company:
Bioptimal International Pte Ltd - Designation:
Regulatory Affairs Intern - Profession:
Others / General Work - Industry:
Manufacturing General / Biomedical / Pharmaceutical - Location:
Boon Lay