Regulatory Affairs Specialist

6 days ago

West Singapore Corestaff Pte Ltd Full time

The incumbent is responsible to draft a regulatory submission and work with the respective authorized market representative in the submission of premarket approval ensuring the device is safe and effective for its intended uses. The incumbent is responsible for reviewing all the product labeling associated with the product and ensuring all claims are consistent with the approved intended use and all materials associated with the device are appropriate.

**Responsibilities**:

- Prepare and maintain a listing of all registered products in all markets and maintain its renewal in a timely manner. Working closely with market authorized representative by providing all the necessary documents for dossier submission. Keeping track of legislation changes and advise on the legal and scientific restraint and requirements, collect, collate and evaluate scientific data.
- Ensure local and international market regulatory requirements are in compliance (HSA, TGA, FDA, EU, others as applicable).
- Participate in regulatory inspection by the regulatory authorities and certification bodies.
- Participate and assist to provide material/information required by Regulatory Authority for import, reimbursement and product registration.
- Ensure all technical documents are updated and ready for regulatory submission. Update when necessary.
- Working closely with market Authorized Representative to ensure products marketed are safe, sterile and effective.
- Any other tasks or projects that are being assigned by the immediate supervisor, as and when required.

**Requirements**:

- In-depth knowledge of the cGMP, market regulations (HSA, FDA, TGA, CFDA, EU) and ISO 13485.
- Understanding of law, regulation and pending regulation.

**How to Apply**:
Lee Yuh Shiuan

Registration Number: R21101101

EA License Number: 18C9027

**Salary**: $3,500.00 - $4,500.00 per month

**Benefits**:

- Health insurance

Schedule:

- Monday to Friday

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