Do you want to build a rewarding career in Healthcare?

We are looking for dynamic individuals who share our Core values of Teamwork, Accountability, Competence, and Compassion

Job Role:

The successful candidate will oversee the preparation, submission, and maintenance of License to Operate, product registrations, monitoring regulatory requirements, and facilitating interactions with the Food and Drug Administration (FDA) and other regulatory agencies

Job Description:

1. Be the official Company Representative of the Company to the Food and Drugs Administration (FDA) and other government/private agencies and institutions as applicable

2. Ensure that the Company’s License to Operate (LTO) with the FDA is up-to-date

3. Manage and maintain registration and renewal of all medical equipment and other products with the FDA and other government/private agencies and institutions as applicable

4. Ensure compliance of the Company to all FDA regulations and other government/private agencies and institutions as applicable

5. Coordinate with the company's Principals to ensure timeliness of regulatory approvals for business continuity.

6. Attend regulatory seminars and trainings as applicable

7. Take the lead during official site/office inspections with FDA and other government/private agencies and institutions as applicable

8. Sign on behalf of the Company for any and all documents directly related to FDA requirements and other government/private agencies and institutions as applicable

9. Coordinate with the Company’s Customs Broker regarding shipment for all medical equipment, products, accessories, peripherals as applicable

10. Coordinate closely with other departments in the organization regarding compliance with FDA and other government/private agencies and institutions as applicable

11. Take the lead/initiative in developing and maintaining quality control and assurance processes

12. Act as Document Controller for all data/records related to FDA and other government/private agencies and institutions matters

13. Other duties as may be assigned by management from time to time

The successful candidate will have the following qualifications:

Registered Pharmacist, Medical Technologist, or other medical related PRC license (active license)

• 2 years of experience in regulatory affairs
• 2 years of experience in product registration
• 2 years of experience in FDA compliance and registration of medical equipment

This is an urgent requirement. We are looking to onboard the successful candidate by May 15, 2025.

Email [email protected]

Please refer to job description.