Junior Regulatory Affairs Specialist

2 weeks ago


Singapore Andaman Medical Full time

We are looking for a Regulatory Affairs Specialist with at least 1 year experience in medical devices and or any related field, who can further assist our team in Thailand in processing medical device registration, determining risk classifications of health products and monitoring trends regarding the industry regulations.
- Preparing and submitting documents related to Change of Ownership and Change Notification of medical devices.
- Preparing and submitting documents to obtain notification from the Authority through various routes, such as Demonstration, Clinical Evaluation, Special Access and other routes.
- Monitoring emerging trends regarding industry regulations to determine potential impact on internal projects and providing and drafting regulatory updates.
- Developing and maintaining Standard Operating Procedures, local working practices, regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Liaising with external parties on matters relating to Singapore medical device regulatory requirements.
- Ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements.

**Salary**: $2,000.00 - $2,500.00 per month

**Benefits**:

- Employee assistance programme
- Professional development

Schedule:

- Day shift
- Monday to Friday

Supplemental pay types:

- Performance bonus

**Experience**:

- Medical Device Regulatory: 1 year (required)



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