Bioptimal International Pte Ltd – Intern, Regulatory Affairs

Company
Bioptimal International Pte Ltd
bioptimalg.com
Designation
Intern, Regulatory Affairs
Date Listed
14 Sep 2021
Job Type
Entry Level / Junior Executive
Intern/TS
Job Period
From 16 Dec 2021, For At Least 6 Months
Profession
Others / General Work
Industry
Manufacturing General / Biomedical / Pharmaceutical
Location Name
36 Jalan Tukang, Singapore
Address
36 Jln Tukang, Singapore 619266
Map
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

  • 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

  • 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.

 

Application Instructions

Related Company Review:

Biosensors International
www.biosensors.com
Type: Health Care Products Manufacturing / Manufacturing
2.7
Biosensors
Pros: Bonuses, good benefits. There are exercise classes every week. Often have the opportunity to travel, training. Shuttle bus every day for staff, very convenient. The pantry is spacious and there is a Nespresso coffee machine. In this company, as long as willing to work hard, it will be able to quickly promoted.
Cons: There are some changes in 2016, but the future will be better. Some employees do not speak Chinese, support is a bit difficult.
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