Regulatory Affairs

1 week ago

Singapore MANDARIN OPTO-MEDIC CO PTE LTD Full time

**Duties**:

- Manage renewal processes of medical device for maintaining regulatory compliance
- Facilitate the dissemination of documentation (eg. Letter of Authorization, Free Sales Certificates, Certificates of Origin, etc) to both internal and external parties
- Serve as internal consultant for basic regulatory affairs support involving issues such as market compliance, recalls, advertising and promotional regulations, or review of proposed regulatory changes.
- Serve as external liaison to government regulatory bodies CHSA, NEA for regulatory compliance
- Perform up-to-date research and monitor current regulations pertaining to product standards and update internal procedures as appropriate
- Correspond with Health Science Authority pertaining to product registration matter

**Requirements**:

- Diploma/degree in Biomedical Science or Biotechnology
- No experience required, training will be provided
- Strong organizational skills
- Good command of written English
- Competent with Microsoft Office and able to work independently

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