Regulatory Affairs Officer

AMT PTE. LTD.
  • Job category
    Engineering, Healthcare / Pharmaceutical, Manufacturing
  • Job level
    Executive
  • Contract type
    Full Time
  • Location
    West
  • Salary
    S$2400 - S$3000

Job Description

The Regulatory Affairs Officer will be involved in the regulatory submissions and renewals of product licenses, in terms of technical dossier preparation, liaising with the relevant competent authorities and post-market activities. You will support the marketing and product development team for all regulatory activities. You will also have the opportunity to drive the product registration activities in different overseas markets.


Roles & Responsibilities:

1. Prepare technical dossiers for submissions to relevant regulatory authorities within a strict timeline.

2. Manage change notification submissions to the relevant regulatory authorities (local and overseas)

3. Liaise and manage communications with the regulatory authorities.

4. Liaise with cross functions department and provide regulatory input in product development projects.

5. Post-market activities which include market vigilance, post-registration approval conditions follow-up, etc.

6. Monitor internal activities and processes for regulatory compliance.

7. Reporting MDR/Adverse Event/FSCA/Recall to regulatory authorities when necessary.

Other activities as assigned


Closing on 20 Mar 2021

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