Company
Bioptimal International Pte Ltd
bioptimalg.com
Designation
Regulatory Affairs Intern
Date Listed
28 Apr 2022
Job Type
Entry Level / Junior Executive
Intern/TS
Job Period
From 10 Jun 2022, For At Least 6 Months
Profession
Others / General Work
Industry
Manufacturing General / Biomedical / Pharmaceutical
Location Name
Singapore
Allowance / Remuneration
$800 monthly
Company Profile
The company is in the medical device business of improving lives through today’s 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 Description
Job Description
- Assist the RA team for local regulatory matters such as HSA submission, SAP and Product Registration (APAC)
- Arrange documents for notarization and legalization
- Administrative support to the RA Team, eg: document delivery, raise invoice, etc.
- Assist in research work for CER preparation for all CCP products
- Singapore – Local regulatory support
- Assist the RA team for local regulatory matters
- 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 shipment out are blocked)
- 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
- Assist RA team’s regulatory projects
- Legalization of documents
- Documents for use overseas 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 the payment for legalization
- Administrative support to the RA Team
- Taking of minutes
- Organization of documents.
- Handling shipment of documents sent locally and overseas
- Ad-hoc project on QMS documentation management and data analysis for audit preparation.
Requirements
- Pursuing Bachelor degree on Mechanical / Chemical / Biomedical Engineering, Pharmaceutical, Biological / Chemistry Sciences
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- Company:
Bioptimal International Pte Ltd - Designation:
Regulatory Affairs Intern - Profession:
Others / General Work - Industry:
Manufacturing General / Biomedical / Pharmaceutical
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